OVERSTITCH™ ENDOSCOPICSUTURING SYSTEM (ESS)INSTRUCTIONS FOR USE

Caution:Please read all instructions prior to use

SINGLE PATIENT USEDISPOSABLE

STERILE EO

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Sterile. Sterilized with ethylene oxide gas.Single use only. Disposable. Do not resterilize.

Caution: Federal (USA) law restricts this deviceto sale, distribution, and use by or on the orderof a physician.

Patent Pending

DISCLAIMER OF WARRANTY AND LIMITATIONOF REMEDY

THERE IS NO EXPRESS OR IMPLIED WARRANTY,INCLUDING WITHOUT LIMITATION ANY IMPLIEDWARRANTY OF MERCHANTABILITY OR FITNESSFOR A PARTICULAR PURPOSE, ON THE APOLLOENDOSURGERY, INC. PRODUCT(S) DESCRIBED INTHIS PUBLICATION. UNDER NO CIRCUMSTANCESSHALL APOLLO ENDOSURGERY, INC. BE LIABLE FORANY DIRECT, INCIDENTAL, OR CONSEQUENTIALDAMAGES OTHER THAN AS EXPRESSLY PROVIDEDBY SPECIFIC LAW. NO PERSON HAS THE AUTHORITYTO BIND APOLLO ENDOSURGERY, INC. TO ANYREPRESENTATION OR WARRANTY EXCEPT ASSPECIFICALLY SET FORTH HEREIN.

DESCRIPTIONS OR SPECIFICATIONS IN APOLLOENDOSURGERY, INC PRINTED MATTER, INCLUDINGTHIS PUBLICATION, ARE MEANT SOLELY TOGENERALLY DESCRIBE THE PRODUCT AT THE TIMEOF MANUFACTURE AND DO NOT CONSTITUTE ANYEXPRESS WARRANTIES.

APOLLO ENDOSURGERY, INC. WILL NOT BERESPONSIBLE FOR ANY DIRECT OR CONSEQUENTIALDAMAGES RESULTING FROM REUSE OF THE PRODUCT.

OverStitchTM Endoscopic Suturing SystemReorder Number: ESS-G00-000

OverStitchTM 3-0 Polyglycolic Acid (PGA) SutureReorder Number: PGA-G30-000

OverStitchTM 2-0 Polypropylene SutureReorder Number: PLY-G20-000

OverStitchTM 3-0 Polypropylene SutureReorder Number: PLY-G30-000

OverStitchTM Suture CinchReorder Number: CNH-G00-000

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1 General System Description

The Apollo Endosurgery OverStitchTM EndoscopicSuturing System (ESS) provides physicians theability to perform tissue apposition within theGastrointestinal (GI) Tract. Additionally, the systemallows the surgeon to ‘reload’ the suture without theneed for removing the endoscope.

The ESS works by delivering a proprietary Anchorand Suture through the channel of the endoscopeand passing both to the Suturing Arm. As necessary,a tissue retractor can be passed down the scope’ssecond channel to pull tissue into the plane of theESS’s Suturing Arm. The ESS has the ability to passthe Anchor through a full thickness bite of tissue.This process can be repeated for placement of acontinuous row of running stitches or terminatedfor an interrupted stitch. To secure each Suture aCinch is passed down the scope’s primary channeland the user deploys the Cinch while applying thedesired amount of suture tension.

The OverStitch product family is comprised of threedevices which include the Endoscopic SuturingSystem (ESS), a choice of Suture, and a SutureCinch. All devices are delivered sterile and sealedin protective packaging.

The Endoscopic Suturing System is comprised of aSystem Handle, an End Cap, and an Anchor Exchange.The End Cap contains a Suturing Arm which tradesan Anchor with the Anchor Exchange and performsthe stitching operations. The opening and closingof the Suturing Arm is controlled by the Handle Grip.The system contains a Retention Wire that ensuresthe End Cap does not inadvertently disengage fromthe tip of the endoscope. The Anchor Exchangeallows for the endoscopic loading and recapture ofan Anchor and Suture.

Figure 1: Endoscopic SuturingSystem in the shipping tray(lid removed)

Anchor Exchange

System Handle

Loading Tube

End Cap

Retention DeviceChannel AdapterBracket

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Figure 2: End Cap – Works in conjunction with the Anchor Exchange to place Stitches

Figure 3: System Handle – Controls operations of the End Cap

Actuation Catheter

Suture Arm

Needle Guard

Tissue Guard

Coupling Ring

Dial Lock

Retention Wire Bead

Override Knob

Handle Grip (Blue)

Handle Body (White)

Handle Grip Lock

Thumb Button

Override Switch

Bracket Coupling

Length CalibrationDial

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The OverStitch Sutures consist of an Anchor andSuture combination that was designed to specificallywork with the Endoscopic Suturing System. TheSuture system was also designed to allow theAnchor to serve as a t-tag, securing the Sutureafter placement. Each Suture is delivered in aSuture Cassette for ease of handling. The Sutureis offered in a combination of a 2-0 or 3-0 sizes inbraided absorbable suture (PGA) or monofilamentnonabsorbable (Polypropylene). The Sutures meetabsorbable and nonabsorbable surgical suturerequirements established by the United StatesPharmacopeia (U.S.P.).

Polyglycolic Acid (PGA) Suture is a coated, braidedsynthetic absorbable surgical suture. It is violetin color and is coated for lubricity. The in-vitroretention strength is 73.0% ± 6.0% at 14 days andis 45.0% ± 6.5% at 21 days. The material absorbsby hydrolysis in 60 to 90 days with virtually notissue reaction. The material is supplied sterile.

Polypropylene Suture is a nonabsorbable surgicalsuture that is blue in color. The polypropylene sutureelicits a minimal acute inflammatory reaction intissues, which is followed by gradual encapsulationof the suture of fibrous connective tissue. Thesesutures are nonabsorbable and no significantchange in strength retention is known to occur in vivo.

The Suture Cinch consists of an instrument todeliver an implantable suture cinch that maintainsthe desired suture tension.

Figure 4: Suture Cassette – the Anchoris recessed below the Tab

Figure 5: Enlarged image ofthe Anchor and Suture

Tab

Suture Cassette

Anchor

Suture

Figure 6: Suture Cinch

SutureLoading Tab

Cinch Handle

Safety Tab

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2 Intended Use

The Apollo Endosurgery Endoscopic Suture Systemis intended for endoscopic placement of suture(s)and approximation of soft tissue.

3 Contraindications

Contraindications include those specific to use of anendoscopic suturing system, and any endoscopicprocedure, which may include, but not limited to,the following:

• This system is not for use when endoscopictechniques generally are contraindicated.

• This system is not for use with malignanttissue.

• Absorbable sutures, should not be usedwhere extended approximation of tissueis required.

4 Warnings

• Do not use a device where the integrity ofthe sterile packaging has been compro-mised or if the device appears damaged.

• Only physicians possessing sufficient skilland experience in similar or the sametechniques should perform endoscopicprocedures.

• Do not attempt to open the Suturing Armin a confined space. Ensure adequateclearance for the fully opened SuturingArm prior to use

• When intubating or extubating with theEndoscopic Suturing System, ensure thatthe endoscope body and the ActuationCatheter are retracted together.

• Ensure that the Handle Grip of theEndoscopic Suturing System is closed andlocked during intubation and extubation.

• Do not force the Anchor Exchange if resistanceis encountered during introduction throughthe scope. Reduce the endoscope angulationuntil the device passes smoothly.

• Ensure that adequate Suture tension ismaintained during introduction of theSuture Cinch.

• With the device installed on the scope,accessories designed to hold the endoscopealone may no longer securely hold onto theendoscope.

• Discard open, unused Sutures.• Users should be familiar with surgical

procedures and techniques involvingabsorbable sutures before employingSynthetic Absorbable Sutures for woundclosure, as the risk of wound dehiscencemay vary with the site of application andthe suture material used.

• Do not remove the Safety Tab from theSuture Cinch handle until the Suture Cinchis ready for final deployment; early removalof the Safety Tab will result in prematureengagement of the Suture Cinch ontothe Suture

• Do not re-sterilize or reprocess

5 Precautions

• All packaged product should be stored in acool, dark, dry place.

• The System may only be used if purchasedfrom Apollo Endosurgery, Inc. or one of itsauthorized agents.

• With the Endoscopic Suturing Systeminstalled, the endoscope’s primary channeleffectively becomes a 3.4-mm channel, andthe secondary channel effectively becomesa 2.3-mm channel.

• Use in the Lower Gastrointestinal tract isonly recommended when accompanied byan access port.

• Use of the Endoscopic Suturing System andthe system components has not been studiedin the esophagus. There is no data on file toshow safety or efficacy of the product in thisanatomy.

• Use caution when maneuvering the systemwhen loaded with an Anchor to avoidunintended contact with delicate tissue.

• The contents of the system and the systemas a whole are not intended for reprocessingor re-sterilization.

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6 Adverse Events: Possible complicationsthat may result from using the EndoscopicSuturing System include, but may not belimited to:

• Hemorrhage• Hematoma• Infection / Sepsis• Pharyngeal, colonic and/or esophageal

perforation• Esophageal, colonic and/or pharyngeal

laceration• Intra-abdominal (hollow or solid) visceral

injury• Aspiration• Wound dehiscence• Acute inflammatory tissue reaction• Death

7 Preparations for Use

7.1 Recommended Accessories:

• Olympus GIF-2T160 Endoscope• Guardus Esophageal Overtube from US

Endoscopy (P/N 00711149)• Minos Overtube (Order Code:

OT-22-80)• Water soluble lubricant• 2.3-mm Rat-Tooth Grasper (MediGlobe

P/N 817460) or similar• 2.3-mm Alligator-Tooth Grasper

(MediGlobe P/N 821460) or similar• Olympus Loop Cutter (FS-5U-1)• Apollo Endosurgery Flexible

Endoscopic Scissors (FES-235-L32)• 20-ml Slip Fit Syringe

7.2 Endoscope Selection andPreparation:

7.2.1 The endoscope must be an OlympusGIF-2T160.

7.2.2 Prepare scope as per institutionalguidelines.

7.2.3 Remove the channel caps from theendoscope if they are installed.

7.3 Endoscopic Suturing SystemPreparation:

7.3.1 Remove the pouched EndoscopicSuturing System from the packaging.Warning: Do not use a device wherethe integrity of the sterile packaginghas been compromised or if thedevice appears damaged.

7.3.2 Open the pouch and transfer the(sterile) tray to a sterile table.

7.3.3 Locate the Channel Adapter Bracket and install it onto the endoscope as illustrated:

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ChannelAdapterBracket

7.3.4 Locate the Retention Device and install it onto the secondary channel side of the ChannelAdapter Bracket. Push down and turn the Retention Device counter-clockwise until it is secure:

RetentionDevice

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7.3.6 Locate the Retention Wire on the End Cap of the Endoscopic Suturing System and back-load itinto the scope’s secondary channel until the End Cap sits flush with the face of the scope:

7.3.7 Remove the Loading Tube from the End Cap Retainer.

RetentionWire

Loading Tube

RetentionWire

End Cap

7.3.5 Locate the Loading Tube. Install it into the End Cap Retainer and push down until the tubebottoms as shown:

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7.3.8 Rotate the Retention Wheel on the Retention Device and slide the Retaining Wire Bead intothe groove:

7.3.9 Connect the Endoscopic Suturing System’s Bracket Coupling to the Channel Adapter Bracket bytwisting clockwise:

RetentionWheel

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7.3.10 To aid in maintaining insufflation pressure and/or vacuum pressure, place the Plug into the lumen ofthe End Cap Retainer:

7.3.11 After installing the Endoscopic Suturing System assembly onto the endoscope, tape the ActuationCatheter to the body of the scope in an area that will remain outside of the patient. This helps toensure the catheter and scope travel together as a system.

Plug

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8 Loading a Suture and Anchor:

8.1 Open the Handle Grip of theEndoscopic Suturing System. TheAnchor Exchange cannot be loadedor removed from the System Handleif the Handle Grip is closed.

8.2 Select the appropriate Suture sizeand type for the desired procedure

8.3 Remove the Suture Cassette fromthe sterile pouchWarning: Do not use a device wherethe integrity of the sterile packaginghas been compromised or if the deviceappears damaged.

8.4 Remove the blue Tab from the frontof the Suture Cassette to exposethe Anchor

8.5 Insert the tip of the Anchor Exchangeinto the Suture Cassette to engagethe Anchor. An audible / tactile“Click” confirms the Anchor is fullyseated in the Anchor Exchange

8.6 Introduce the Anchor Exchangedown the Handle Body through theworking channel of the scope. Theslot in the side of the Handle Bodywas made to accommodate the Suture.Warning: Do not force the AnchorExchange if resistance is encounteredduring introduction through the scope.Reduce the endoscope angulationuntil the device passes smoothly.

8.7 Continue to advance the AnchorExchange and align both AlignmentPins with the handle slot. Continueuntil it is fully inserted into the handlethen turn the Anchor ExchangeLocking Knob counter-clockwise.

Anchor Exchange

Anchor ExchangeAlignment Pins (Two)

Anchor ExchangeLocking Knob

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9 Setting the length of theEndoscopic Suturing Systemfor the individual scope:

9.1 Set-up Procedure UsingEndoscopic Visualization

Note: the system length only needs to beset once at the start of each procedure

9.1.1 If not already completed, connectthe endoscope to the endoscopictower and power the endoscope “ON”

9.1.2 Lay the endoscope and EndoscopicSuturing System flat on a table

9.1.3 If closed, open the EndoscopicSuturing System Handle Grip

9.1.4 Shuttle the System Handle downand endoscopically look for theLength Adjustment Mark on theAnchor Exchange catheter. At thispoint the Length Adjustment Markwill likely be inside of the scopeindicating that the user needs tolengthen the device

9.1.5 Shuttle the System Handle back out.9.1.6 Open the Dial Lock on the Length

Calibration Dial9.1.7 Turn the Length Calibration Dial

clockwise several clicks.9.1.8 Shuttle the System Handle down

SLOWLY.9.1.9 Endoscopically look for the Length

Adjustment Mark.9.1.10 The ideal location for the Length

Adjustment Mark is when the middleof the mark lines up with the upperedge of the end cap’s Tissue Guard,as shown below. Continue to turnthe Length Calibration Dial until theLength Adjustment Mark lines upwith the upper edge of the TissueGuard, as shown:

Dashed Line Drawn Across theUpper Edge of the Tissue Guard

Length AdjustmentMark

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Length Adjustment Mark to be centeredat the top of the End Cap’s tissue guard

9.1.11 Once in position, engage the DialLock on the Length Adjustment Dialto secure the system position.

9.1.12 Remove the System Handle from“override” mode by turning theOverride Knob on the left side ofthe handle toward the user.

9.2 Set-up Procedure Using theUnaided Eye

9.2.1 Lay the endoscope and EndoscopicSuturing System flat on a table

9.2.2 If closed, open the EndoscopicSuturing System Handle Grip

9.2.3 Shuttle the System Handle downand look for the Length AdjustmentMark on the Anchor Exchangecatheter. At this point, the LengthAdjustment Mark will likely be insideof the scope indicating that the userneeds to lengthen the device

9.2.4 Shuttle the System Handle back out.9.2.5 Open the Dial Lock on the Length

Calibration Dial

9.2.6 Turn the Length Calibration Dialclockwise several clicks.

9.2.7 Shuttle the System Handle downSLOWLY.

9.2.8 Look for the Length AdjustmentMark.

9.2.9 The ideal location for the LengthAdjustment Mark is when the middleof the mark lines up with the upperedge of the end cap’s Tissue Guard,as shown below. Continue to turnthe Length Calibration Dial until theLength Adjustment Mark lines upwith the upper edge of the TissueGuard, as shown:

9.2.10 Once in position, engage the DialLock on the Length Adjustment Dialto secure the system position.

9.2.11 Remove the System Handle from“override” mode by turning theOverride Knob on the left side ofthe handle toward the user.

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10 Device Insertion:

10.1 Ensure that the Suturing Arm at thetip of the endoscope is in the closedposition by locking the Handle Gripclosed. The locking mechanism isengaged by squeezing the HandleGrip Lock while the Handle Grip is inthe closed position.Warning: Ensure that the HandleGrip of the Endoscopic SuturingSystem is closed and locked duringintubation and extubation.

10.2 Verify the System Handle is instandard suturing mode by turningthe Override Knob to the off position.Note, when the Override Knob issitting flush against the Handle Gripsurface the System Handle is in thestandard suturing mode. If theOverride Knob is raised above thehandle surface, simple turn the OverrideKnob 90 degrees clockwise to en-able the standard suturing mode.

10.3 Generously lubricate the outside ofthe endoscope and the EndoscopicSuturing System with a water solublelubricant.

10.4 Deliver the system to the physician’sdesired location through standardendoscopic techniques.

11 Suturing:

11.1 With the device Handle Grip closedand the Handle Grip Lock engaged,transfer the Anchor to the End Cap’sSuturing Arm through the followingactions:11.1.1 Plunge the System Handle

downward11.1.2 When the System Handle

bottoms out against thescope depress and holdthe Thumb Button

11.1.3 While holding the ThumbButton down, shuttle theSystem Handle back out toit’s original position

11.2 In preparation for stitching ensure thatadequate clearance exists alongside

the endoscope to accommodateopening of the Suturing ArmWarning: Do not attempt to openthe Suturing Arm in a confined space.Ensure adequate clearance for the fullyopened Suturing Arm prior to use.

11.3 Once adequate clearance has beenestablished, open the Suturing Armby squeezing and releasing theHandle Grip

11.4 With the aid of a grasper or similardevice (2.3-mm compatible orsmaller – refer to section 7.1), pulla wedge of tissue into the suturingwindow.

11.5 When the tissue is aligned for suturing,close the System Handle andactivate the Handle Grip Lock(to lock the handle closed)

11.6 In one continual motion shuttlethe System Handle completelydownward and back to the originalposition

11.7 Open the System Handle bysqueezing the Handle Grip

11.8 At this time, a grasper can be usedto push out extra suture length

11.9 Adjust the endoscope positionslightly to clear the tissue from theEnd Cap

11.10 Close Handle Grip and engage theHandle Grip Lock

11.11 Transfer the Anchor to the EndCap’s Suturing Arm through thefollowing actions:11.11.1 Shuttle the System Handle

downward11.11.2 When the System Handle

bottoms out against thescope depress and holdthe Thumb Button

11.11.3 While holding the ThumbButton down, shuttle theSystem Handle back outto it’s original position

11.12 The endoscope can then bemaneuvered into position for placingan additional stitch

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12 Dropping the Anchor

In preparation for cinching the Anchor andSuture must be dropped at the treatment site

12.1 Place the System Handle into overridemode by turning the Override Knobon the side of the System Handleaway from the user. This will raisethe Override Knob above the HandleGrip surface

12.2 Open the System Handle by squeezingthe Handle Grip

12.3 Push down the thumb OverrideSwitch until it ‘Clicks’ in the downposition

12.4 Plunge the System Handle downuntil the Anchor is visible outside ofthe endoscope channel

12.5 Press and hold the Thumb Button todeposit the Anchor

12.6 After the Anchor was droppedshuttle the System Handle back tothe original position

12.7 Remove the System Handle from“override” mode by turning theOverride Knob on the left side of thehandle toward the user

13 Cinching

13.1 Ensure the endoscope has little tono articulation before performing thecinching operation.

13.2 Open the System Handle by squeezingthe Handle Grip

13.3 Completely remove the AnchorExchange from the System Handleby twisting the Locking Knob clockwiseand pulling the device completelyout of the System Handle

13.4 Uncoil the cinch in preparation for useWarning: Do not remove the SafetyTab from the Cinch handle until theCinch is ready for final deployment;early removal of the Safety Tab willresult in premature engagement ofthe Cinch onto the Suture

13.5 Slide the free end of the Suturethrough the window of the SutureCinch’s Suture Loading Tab asshown below:

13.6 Grasp the base of the Suture LoadingTab and pull the device out of theSuture Cinch

13.7 To insert the Suture Cinch throughthe System Handle and the endoscope,grasp the free end of the Suture andapply slight tension while the SutureCinch is advancedWarning: Ensure that adequateSuture tension is maintained duringintroduction of the Suture Cinch

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13.8 Extend the Suture Cinch out thedistal end of the scope

13.9 Apply the desired amount of Suturetension by pulling on the free end ofthe Suture that extends out theSystem Handle

13.10 Remove and discard the Safety Tabfrom the Cinch Handle

13.11 Actuate the Suture Cinch by firmlysqueezing the handle. This willdeploy the Suture Cinch and cut theremaining Suture.

13.12 Using endoscopic visualizationensure that the Suture is capturedand the Suture Cinch is secure.

13.13 Retract the Suture Cinch and excessSuture.

14 System Removal from the Patient:

14.1 To remove the device, make sure theEnd Cap is locked in the closed positionby squeezing the Handle Grip andactivating the Handle Grip lock.Warning: Ensure that the HandleGrip of the Endoscopic SuturingSystem is closed and locked duringintubation and extubation.

14.2 While holding the Actuation Catheteron the outside of the endoscope,gently retract the endoscope anEndoscopic Suturing System fromthe patient.Warning: When intubating or extubatingwith the Endoscopic Suturing System,ensure that the endoscope body andthe Actuation Catheter are retractedtogether.

15 System Removal from the Endoscope:

15.1 Rotate the Retention Wheel of theRetention Device and slide theRetaining Wire Bead out of theRetention Wheel.

15.2 Remove the System Handle from theChannel Adapter Bracket by twistingthe Coupling Ring counter-clockwise

15.3 Pull off the End Cap from the distalend of the endoscope and removethe Retention Wire from within thescope channel.

15.4 Remove the Retention Device bytwisting it clockwise

15.5 Slide up the Channel AdapterBracket and pull it off the scope.

15.6 Dispose of all devices and materialsin a manner conducive to the hospital’sinternal policies

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Steps to Resolve Condition

1. If the Anchor is in the End Cap Suturing Arm, continue with this step;otherwise, go to step 2.

a. Remove the Anchor Exchange from the deviceb. Pass a grasper through the handle to grab the Anchor or Suture

and close the Suturing Arm.c. With the grasper holding the Suturing Arm closed, extract the

Endoscopic Suturing System and endoscope together.

2. If the Anchor is not in the End Cap receptaclea. Remove the Anchor Exchange from the deviceb. Pass a grasper and/or snare down the primary channel to grab

the Suturing Arm and pull it closedc. With the grasper holding the Suturing Arm closed, extract the

Endoscopic Suturing System and endoscope together.

3. If unable to pull the End Cap Suturing Arm closed and an overtube isin place:

a. Rotate the Retention Device Retention Wheel and remove theRetention Wire Bead.

b. Remove the Anchor Exchange from the System Handlec. With a set of graspers, push against the End Cap until it releases

from the endoscope.d. Gently manipulate the End Cap to pull it into the overtube –

ensure the End Cap is not dragged through unprotected anatomye. Remove using standard endoscopic technique.

4. If unable to pull the End Cap Suturing Arm closed and an overtube isnot in place:Eject the End Cap and remove by the following means:

a. Rotate the Retention Device Retention Wheel and remove theRetention Wire Bead.

b. Remove the Anchor Exchange from the System Handlec. With a set of graspers, push against the End Cap until it releases

from the endoscope.d. Gently retract the endoscope to the point where the End Cap is

visually confirmed to be free of the endoscope.e. Continue retracting the scope while visually confirming that the

Retention Wire continues to slide free of the endoscope.

16 Troubleshooting

Current Condition

End Cap Suturing ArmStuck Open

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Steps to Resolve Condition (cont)

f. Remove the endoscope from the patientg. Remove the System Handle from the Channel Adapter Bracket.h. Cut the System Handle free of the Actuation Catheter.i. Back feed the End Cap’s Actuation Catheter and the

Retention Wire through a compatible overtube.j. While maintaining position of the End Cap’s Actuation Catheter,

introduce the overtube into the patient.k. Once the End Cap is visible through the endoscope, utilize a

compatible grasper to pull the End Cap into the overtube.l. Remove using standard endoscopic technique.

Steps to Resolve Condition

First line of defense:1. Ensure the System Handle is shuttled all of the way out2. Open the System Handle by squeezing the Handle Grip – ensure

the Handle Grip Lock is disengaged3. Gently steer the endoscope tip to allow the End Cap to open naturally

Severe Entrapment:Eject the End Cap and remove by the following means:

1. Follow the instructions on the prior section to insert an overtubeand advance it to the End Cap.

2. Once the End Cap is visible through the endoscope, separate theEnd Cap assembly from the tissue using standard endoscopictechniques.

3. Pull the End Cap into the overtube and remove using standardendoscopic techniques.

Steps to Resolve Condition

1. Pass a compatible grasper down the secondary channel andgrasp the Suture. While holding the graspers on the Suture, pullthe Cinch out of the endoscope and the System Handle. If theCinch cannot be removed from the system, continue to step 2.

2. Regardless of the location of the Cinch, ensure that Cinch hasbeen fully deployed. If not, deploy the Cinch per the “Cinching”section of the IFU. If the Cinch cannot be removed from the systemafter deployment, continue to step 3.

3. Remove any accessory from the endoscope’s secondary channeland pass the compatible loop cutter down the secondary channel.Use the loop cutter to cut the Suture between the surgical site andthe Cinch. This will free the system for removal.

Current Condition

Suture Cinch is stuckon the Suture

Current Condition

End Cap Suturing Armis Stuck in Tissue

Current Condition

End Cap Suturing ArmStuck Open

Description Symbol

Consult instructions for use

Usage Restriction(Single Use Only / Do Not Reuse)

Sterile(Sterilized Using Ethylene Oxide)

Catalog Number

Manufactured By

CautionFederal law restricts this deviceto sale by or on the order of a(licensed healthcare practitioner)

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CautionConsult accompanyingdocuments

Do Not Resterilize

Expiration Date

Lot Number

Do not use if package hasbeen opened or damaged

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