Overstitch - the new offering from Apollo Endosurgery

1. OVERSTITCH™ ENDOSCOPIC
SUTURING SYSTEM (ESS)
INSTRUCTIONS FOR USE
Caution:
Please read all instructions prior to use
STERILE EO
SINGLE PATIENT USE
DISPOSABLE

2. Sterile. Sterilized with ethylene oxide gas.
Single use only. Disposable. Do not resterilize.
Caution: Federal (USA) law restricts this device
to sale, distribution, and use by or on the order
of a physician.
Patent Pending
DISCLAIMER OF WARRANTY AND LIMITATION
OF REMEDY
THERE IS NO EXPRESS OR IMPLIED WARRANTY,
INCLUDING WITHOUT LIMITATION ANY IMPLIED
WARRANTY OF MERCHANTABILITY OR FITNESS
FOR A PARTICULAR PURPOSE, ON THE APOLLO
ENDOSURGERY, INC. PRODUCT(S) DESCRIBED IN
THIS PUBLICATION. UNDER NO CIRCUMSTANCES
SHALL APOLLO ENDOSURGERY, INC. BE LIABLE FOR
ANY DIRECT, INCIDENTAL, OR CONSEQUENTIAL
DAMAGES OTHER THAN AS EXPRESSLY PROVIDED
BY SPECIFIC LAW. NO PERSON HAS THE AUTHORITY
TO BIND APOLLO ENDOSURGERY, INC. TO ANY
REPRESENTATION OR WARRANTY EXCEPT AS
SPECIFICALLY SET FORTH HEREIN.
DESCRIPTIONS OR SPECIFICATIONS IN APOLLO
ENDOSURGERY, INC PRINTED MATTER, INCLUDING
THIS PUBLICATION, ARE MEANT SOLELY TO
GENERALLY DESCRIBE THE PRODUCT AT THE TIME
OF MANUFACTURE AND DO NOT CONSTITUTE ANY
EXPRESS WARRANTIES.
APOLLO ENDOSURGERY, INC. WILL NOT BE
RESPONSIBLE FOR ANY DIRECT OR CONSEQUENTIAL
DAMAGES RESULTING FROM REUSE OF THE PRODUCT.
OverStitchTM Endoscopic Suturing System
Reorder Number: ESS-G00-000
OverStitchTM 3-0 Polyglycolic Acid (PGA) Suture
Reorder Number: PGA-G30-000
OverStitchTM 2-0 Polypropylene Suture
Reorder Number: PLY-G20-000
OverStitchTM 3-0 Polypropylene Suture
Reorder Number: PLY-G30-000
OverStitchTM Suture Cinch
Reorder Number: CNH-G00-000
2

3. 1 General System Description The OverStitch product family is comprised of three
devices which include the Endoscopic Suturing
The Apollo Endosurgery OverStitchTM Endoscopic System (ESS), a choice of Suture, and a Suture
Suturing System (ESS) provides physicians the Cinch. All devices are delivered sterile and sealed
ability to perform tissue apposition within the in protective packaging.
Gastrointestinal (GI) Tract. Additionally, the system
allows the surgeon to ‘reload’ the suture without the The Endoscopic Suturing System is comprised of a
need for removing the endoscope. System Handle, an End Cap, and an Anchor Exchange.
The End Cap contains a Suturing Arm which trades
The ESS works by delivering a proprietary Anchor an Anchor with the Anchor Exchange and performs
and Suture through the channel of the endoscope the stitching operations. The opening and closing
and passing both to the Suturing Arm. As necessary, of the Suturing Arm is controlled by the Handle Grip.
a tissue retractor can be passed down the scope’s The system contains a Retention Wire that ensures
second channel to pull tissue into the plane of the the End Cap does not inadvertently disengage from
ESS’s Suturing Arm. The ESS has the ability to pass the tip of the endoscope. The Anchor Exchange
the Anchor through a full thickness bite of tissue. allows for the endoscopic loading and recapture of
This process can be repeated for placement of a an Anchor and Suture.
continuous row of running stitches or terminated
for an interrupted stitch. To secure each Suture a
Cinch is passed down the scope’s primary channel
and the user deploys the Cinch while applying the
desired amount of suture tension.
Anchor Exchange
End Cap
System Handle
Loading Tube
Channel Adapter
Retention Device Bracket
Figure 1: Endoscopic Suturing
System in the shipping tray
(lid removed)
3

4. Tissue Guard
Actuation Catheter
Suture Arm
Needle Guard
Figure 2: End Cap – Works in conjunction with the Anchor Exchange to place Stitches
Handle Grip (Blue) Handle Grip Lock
Coupling Ring
Dial Lock
Bracket Coupling Thumb Button
Length Calibration
Dial
Override Switch
Handle Body (White)
Override Knob
Retention Wire Bead
Figure 3: System Handle – Controls operations of the End Cap
4

5. The OverStitch Sutures consist of an Anchor and Suture Cassette
Suture combination that was designed to specifically
Tab
work with the Endoscopic Suturing System. The
Suture system was also designed to allow the
Anchor to serve as a t-tag, securing the Suture
after placement. Each Suture is delivered in a
Suture Cassette for ease of handling. The Suture
is offered in a combination of a 2-0 or 3-0 sizes in
braided absorbable suture (PGA) or monofilament
nonabsorbable (Polypropylene). The Sutures meet
absorbable and nonabsorbable surgical suture
requirements established by the United States
Pharmacopeia (U.S.P.). Figure 4: Suture Cassette – the Anchor
is recessed below the Tab
Polyglycolic Acid (PGA) Suture is a coated, braided Suture
synthetic absorbable surgical suture. It is violet Anchor
in color and is coated for lubricity. The in-vitro
retention strength is 73.0% ± 6.0% at 14 days and
is 45.0% ± 6.5% at 21 days. The material absorbs
by hydrolysis in 60 to 90 days with virtually no
tissue reaction. The material is supplied sterile.
Polypropylene Suture is a nonabsorbable surgical
suture that is blue in color. The polypropylene suture
elicits a minimal acute inflammatory reaction in
tissues, which is followed by gradual encapsulation Figure 5: Enlarged image of
the Anchor and Suture
of the suture of fibrous connective tissue. These
sutures are nonabsorbable and no significant
change in strength retention is known to occur in vivo.
Suture
Loading Tab
The Suture Cinch consists of an instrument to
deliver an implantable suture cinch that maintains
the desired suture tension.
Cinch Handle
Figure 6: Suture Cinch
Safety Tab
5

6. 2 Intended Use • Discard open, unused Sutures.
• Users should be familiar with surgical
The Apollo Endosurgery Endoscopic Suture System
procedures and techniques involving
is intended for endoscopic placement of suture(s)
absorbable sutures before employing
and approximation of soft tissue.
Synthetic Absorbable Sutures for wound
closure, as the risk of wound dehiscence
3 Contraindications
may vary with the site of application and
Contraindications include those specific to use of an the suture material used.
endoscopic suturing system, and any endoscopic • Do not remove the Safety Tab from the
procedure, which may include, but not limited to, Suture Cinch handle until the Suture Cinch
the following: is ready for final deployment; early removal
of the Safety Tab will result in premature
• This system is not for use when endoscopic
engagement of the Suture Cinch onto
techniques generally are contraindicated.
the Suture
• This system is not for use with malignant
• Do not re-sterilize or reprocess
tissue.
• Absorbable sutures, should not be used 5 Precautions
where extended approximation of tissue
is required. • All packaged product should be stored in a
cool, dark, dry place.
4 Warnings • The System may only be used if purchased
from Apollo Endosurgery, Inc. or one of its
• Do not use a device where the integrity of
authorized agents.
the sterile packaging has been compro-
mised or if the device appears damaged. • With the Endoscopic Suturing System
installed, the endoscope’s primary channel
• Only physicians possessing sufficient skill
effectively becomes a 3.4-mm channel, and
and experience in similar or the same
the secondary channel effectively becomes
techniques should perform endoscopic
a 2.3-mm channel.
procedures.
• Use in the Lower Gastrointestinal tract is
• Do not attempt to open the Suturing Arm
only recommended when accompanied by
in a confined space. Ensure adequate
an access port.
clearance for the fully opened Suturing
Arm prior to use • Use of the Endoscopic Suturing System and
the system components has not been studied
• When intubating or extubating with the
in the esophagus. There is no data on file to
Endoscopic Suturing System, ensure that
show safety or efficacy of the product in this
the endoscope body and the Actuation
anatomy.
Catheter are retracted together.
• Use caution when maneuvering the system
• Ensure that the Handle Grip of the
when loaded with an Anchor to avoid
Endoscopic Suturing System is closed and
unintended contact with delicate tissue.
locked during intubation and extubation.
• The contents of the system and the system
• Do not force the Anchor Exchange if resistance
as a whole are not intended for reprocessing
is encountered during introduction through
or re-sterilization.
the scope. Reduce the endoscope angulation
until the device passes smoothly.
• Ensure that adequate Suture tension is
maintained during introduction of the
Suture Cinch.
• With the device installed on the scope,
accessories designed to hold the endoscope
alone may no longer securely hold onto the
endoscope.
6

7. 6 Adverse Events: Possible complications 7.2 Endoscope Selection and
that may result from using the Endoscopic Preparation:
Suturing System include, but may not be
7.2.1 The endoscope must be an Olympus
limited to:
GIF-2T160.
• Hemorrhage 7.2.2 Prepare scope as per institutional
• Hematoma guidelines.
• Infection / Sepsis 7.2.3 Remove the channel caps from the
• Pharyngeal, colonic and/or esophageal endoscope if they are installed.
perforation 7.3 Endoscopic Suturing System
• Esophageal, colonic and/or pharyngeal Preparation:
laceration
• Intra-abdominal (hollow or solid) visceral 7.3.1 Remove the pouched Endoscopic
injury Suturing System from the packaging.
• Aspiration Warning: Do not use a device where
the integrity of the sterile packaging
• Wound dehiscence
has been compromised or if the
• Acute inflammatory tissue reaction device appears damaged.
• Death
7.3.2 Open the pouch and transfer the
7 Preparations for Use (sterile) tray to a sterile table.
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

8. 7.3.3 Locate the Channel Adapter Bracket and install it onto the endoscope as illustrated:
Channel
Adapter
Bracket
7.3.4 Locate the Retention Device and install it onto the secondary channel side of the Channel
Adapter Bracket. Push down and turn the Retention Device counter-clockwise until it is secure:
Retention
Device
8

9. 7.3.5 Locate the Loading Tube. Install it into the End Cap Retainer and push down until the tube
bottoms as shown:
Loading Tube
7.3.6 Locate the Retention Wire on the End Cap of the Endoscopic Suturing System and back-load it
into the scope’s secondary channel until the End Cap sits flush with the face of the scope:
Retention
Wire
End Cap
Retention
Wire
7.3.7 Remove the Loading Tube from the End Cap Retainer.
9

10. 7.3.8 Rotate the Retention Wheel on the Retention Device and slide the Retaining Wire Bead into
the groove:
Retention
Wheel
7.3.9 Connect the Endoscopic Suturing System’s Bracket Coupling to the Channel Adapter Bracket by
twisting clockwise:
10

11. 7.3.10 To aid in maintaining insufflation pressure and/or vacuum pressure, place the Plug into the lumen of
the End Cap Retainer:
Plug
7.3.11 After installing the Endoscopic Suturing System assembly onto the endoscope, tape the Actuation
Catheter to the body of the scope in an area that will remain outside of the patient. This helps to
ensure the catheter and scope travel together as a system.
11

12. 8 Loading a Suture and Anchor:
8.1 Open the Handle Grip of the
Endoscopic Suturing System. The
Anchor Exchange cannot be loaded
or removed from the System Handle
if the Handle Grip is closed.
8.2 Select the appropriate Suture size
and type for the desired procedure
8.3 Remove the Suture Cassette from
Anchor Exchange
the sterile pouch
Warning: Do not use a device where
the integrity of the sterile packaging
has been compromised or if the device
appears damaged.
8.4 Remove the blue Tab from the front
of the Suture Cassette to expose
the Anchor
8.5 Insert the tip of the Anchor Exchange
into the Suture Cassette to engage
the Anchor. An audible / tactile
“Click” confirms the Anchor is fully
seated in the Anchor Exchange
8.6 Introduce the Anchor Exchange Anchor Exchange
down the Handle Body through the Locking Knob
working channel of the scope. The
slot in the side of the Handle Body
was made to accommodate the Suture.
Anchor Exchange
Warning: Do not force the Anchor Alignment Pins (Two)
Exchange if resistance is encountered
during introduction through the scope.
Reduce the endoscope angulation
until the device passes smoothly.
8.7 Continue to advance the Anchor
Exchange and align both Alignment
Pins with the handle slot. Continue
until it is fully inserted into the handle
then turn the Anchor Exchange
Locking Knob counter-clockwise.
12

13. 9 Setting the length of the 9.1.5 Shuttle the System Handle back out.
Endoscopic Suturing System 9.1.6 Open the Dial Lock on the Length
for the individual scope: Calibration Dial
9.1.7 Turn the Length Calibration Dial
9.1 Set-up Procedure Using clockwise several clicks.
Endoscopic Visualization 9.1.8 Shuttle the System Handle down
SLOWLY.
Note: the system length only needs to be
set once at the start of each procedure 9.1.9 Endoscopically look for the Length
Adjustment Mark.
9.1.1 If not already completed, connect
the endoscope to the endoscopic 9.1.10 The ideal location for the Length
tower and power the endoscope “ON” Adjustment Mark is when the middle
of the mark lines up with the upper
9.1.2 Lay the endoscope and Endoscopic
edge of the end cap’s Tissue Guard,
Suturing System flat on a table
as shown below. Continue to turn
9.1.3 If closed, open the Endoscopic the Length Calibration Dial until the
Suturing System Handle Grip Length Adjustment Mark lines up
9.1.4 Shuttle the System Handle down with the upper edge of the Tissue
and endoscopically look for the Guard, as shown:
Length Adjustment Mark on the
Anchor Exchange catheter. At this
point the Length Adjustment Mark
will likely be inside of the scope
indicating that the user needs to
lengthen the device
Length Adjustment
Mark
Dashed Line Drawn Across the
Upper Edge of the Tissue Guard
13

14. 9.1.11 Once in position, engage the Dial 9.2.6 Turn the Length Calibration Dial
Lock on the Length Adjustment Dial clockwise several clicks.
to secure the system position. 9.2.7 Shuttle the System Handle down
9.1.12 Remove the System Handle from SLOWLY.
“override” mode by turning the 9.2.8 Look for the Length Adjustment
Override Knob on the left side of Mark.
the handle toward the user.
9.2.9 The ideal location for the Length
9.2 Set-up Procedure Using the Adjustment Mark is when the middle
Unaided Eye of the mark lines up with the upper
edge of the end cap’s Tissue Guard,
9.2.1 Lay the endoscope and Endoscopic as shown below. Continue to turn
Suturing System flat on a table the Length Calibration Dial until the
9.2.2 If closed, open the Endoscopic Length Adjustment Mark lines up
Suturing System Handle Grip with the upper edge of the Tissue
Guard, as shown:
9.2.3 Shuttle the System Handle down
and look for the Length Adjustment 9.2.10 Once in position, engage the Dial
Mark on the Anchor Exchange Lock on the Length Adjustment Dial
catheter. At this point, the Length to secure the system position.
Adjustment Mark will likely be inside 9.2.11 Remove the System Handle from
of the scope indicating that the user “override” mode by turning the
needs to lengthen the device Override Knob on the left side of
9.2.4 Shuttle the System Handle back out. the handle toward the user.
9.2.5 Open the Dial Lock on the Length
Calibration Dial
Length Adjustment Mark to be centered
at the top of the End Cap’s tissue guard
14

15. 10 Device Insertion: the endoscope to accommodate
opening of the Suturing Arm
10.1 Ensure that the Suturing Arm at the
Warning: Do not attempt to open
tip of the endoscope is in the closed
the Suturing Arm in a confined space.
position by locking the Handle Grip
Ensure adequate clearance for the fully
closed. The locking mechanism is
opened Suturing Arm prior to use.
engaged by squeezing the Handle
Grip Lock while the Handle Grip is in 11.3 Once adequate clearance has been
the closed position. established, open the Suturing Arm
by squeezing and releasing the
Warning: Ensure that the Handle
Handle Grip
Grip of the Endoscopic Suturing
System is closed and locked during 11.4 With the aid of a grasper or similar
intubation and extubation. device (2.3-mm compatible or
smaller – refer to section 7.1), pull
10.2 Verify the System Handle is in
a wedge of tissue into the suturing
standard suturing mode by turning
window.
the Override Knob to the off position.
Note, when the Override Knob is 11.5 When the tissue is aligned for suturing,
sitting flush against the Handle Grip close the System Handle and
surface the System Handle is in the activate the Handle Grip Lock
standard suturing mode. If the (to lock the handle closed)
Override Knob is raised above the 11.6 In one continual motion shuttle
handle surface, simple turn the Override the System Handle completely
Knob 90 degrees clockwise to en- downward and back to the original
able the standard suturing mode. position
10.3 Generously lubricate the outside of 11.7 Open the System Handle by
the endoscope and the Endoscopic squeezing the Handle Grip
Suturing System with a water soluble 11.8 At this time, a grasper can be used
lubricant. to push out extra suture length
10.4 Deliver the system to the physician’s 11.9 Adjust the endoscope position
desired location through standard slightly to clear the tissue from the
endoscopic techniques. End Cap
11.10 Close Handle Grip and engage the
11 Suturing:
Handle Grip Lock
11.1 With the device Handle Grip closed 11.11 Transfer the Anchor to the End
and the Handle Grip Lock engaged, Cap’s Suturing Arm through the
transfer the Anchor to the End Cap’s following actions:
Suturing Arm through the following 11.11.1 Shuttle the System Handle
actions: downward
11.1.1 Plunge the System Handle 11.11.2 When the System Handle
downward bottoms out against the
11.1.2 When the System Handle scope depress and hold
bottoms out against the the Thumb Button
scope depress and hold 11.11.3 While holding the Thumb
the Thumb Button Button down, shuttle the
11.1.3 While holding the Thumb System Handle back out
Button down, shuttle the to it’s original position
System Handle back out to 11.12 The endoscope can then be
it’s original position maneuvered into position for placing
11.2 In preparation for stitching ensure that an additional stitch
adequate clearance exists alongside
15

16. 12 Dropping the Anchor 13.5 Slide the free end of the Suture
through the window of the Suture
In preparation for cinching the Anchor and Cinch’s Suture Loading Tab as
Suture must be dropped at the treatment site shown below:
12.1 Place the System Handle into override
mode by turning the Override Knob
on the side of the System Handle
away from the user. This will raise
the Override Knob above the Handle
Grip surface
12.2 Open the System Handle by squeezing
the Handle Grip
12.3 Push down the thumb Override
Switch until it ‘Clicks’ in the down
position
12.4 Plunge the System Handle down
until the Anchor is visible outside of
the endoscope channel
12.5 Press and hold the Thumb Button to
deposit the Anchor
12.6 After the Anchor was dropped
shuttle the System Handle back to
the original position
12.7 Remove the System Handle from
“override” mode by turning the
Override Knob on the left side of the
handle toward the user
13 Cinching
13.1 Ensure the endoscope has little to
no articulation before performing the
cinching operation. 13.6 Grasp the base of the Suture Loading
13.2 Open the System Handle by squeezing Tab and pull the device out of the
the Handle Grip Suture Cinch
13.3 Completely remove the Anchor 13.7 To insert the Suture Cinch through
Exchange from the System Handle the System Handle and the endoscope,
by twisting the Locking Knob clockwise grasp the free end of the Suture and
and pulling the device completely apply slight tension while the Suture
out of the System Handle Cinch is advanced
13.4 Uncoil the cinch in preparation for use Warning: Ensure that adequate
Warning: Do not remove the Safety Suture tension is maintained during
Tab from the Cinch handle until the introduction of the Suture Cinch
Cinch is ready for final deployment;
early removal of the Safety Tab will
result in premature engagement of
the Cinch onto the Suture
16

17. 13.8 Extend the Suture Cinch out the 15 System Removal from the Endoscope:
distal end of the scope
15.1 Rotate the Retention Wheel of the
13.9 Apply the desired amount of Suture
Retention Device and slide the
tension by pulling on the free end of
Retaining Wire Bead out of the
the Suture that extends out the
Retention Wheel.
System Handle
15.2 Remove the System Handle from the
13.10 Remove and discard the Safety Tab
Channel Adapter Bracket by twisting
from the Cinch Handle
the Coupling Ring counter-clockwise
13.11 Actuate the Suture Cinch by firmly
15.3 Pull off the End Cap from the distal
squeezing the handle. This will
end of the endoscope and remove
deploy the Suture Cinch and cut the
the Retention Wire from within the
remaining Suture.
scope channel.
13.12 Using endoscopic visualization
15.4 Remove the Retention Device by
ensure that the Suture is captured
twisting it clockwise
and the Suture Cinch is secure.
15.5 Slide up the Channel Adapter
13.13 Retract the Suture Cinch and excess
Bracket and pull it off the scope.
Suture.
15.6 Dispose of all devices and materials
14 System Removal from the Patient: in a manner conducive to the hospital’s
internal policies
14.1 To remove the device, make sure the
End Cap is locked in the closed position
by squeezing the Handle Grip and
activating the Handle Grip lock.
Warning: Ensure that the Handle
Grip of the Endoscopic Suturing
System is closed and locked during
intubation and extubation.
14.2 While holding the Actuation Catheter
on the outside of the endoscope,
gently retract the endoscope an
Endoscopic Suturing System from
the patient.
Warning: When intubating or extubating
with the Endoscopic Suturing System,
ensure that the endoscope body and
the Actuation Catheter are retracted
together.
17

18. 16 Troubleshooting
Current Condition 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 device
b. 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 receptacle
a. Remove the Anchor Exchange from the device
b. Pass a grasper and/or snare down the primary channel to grab
the Suturing Arm and pull it closed
c. 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 is
in place:
End Cap Suturing Arm
Stuck Open a. Rotate the Retention Device Retention Wheel and remove the
Retention Wire Bead.
b. Remove the Anchor Exchange from the System Handle
c. 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 anatomy
e. Remove using standard endoscopic technique.
4. If unable to pull the End Cap Suturing Arm closed and an overtube is
not in place:
Eject the End Cap and remove by the following means:
a. Rotate the Retention Device Retention Wheel and remove the
Retention Wire Bead.
b. Remove the Anchor Exchange from the System Handle
c. 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.
18

19. Current Condition Steps to Resolve Condition (cont)
f. Remove the endoscope from the patient
g. Remove the System Handle from the Channel Adapter Bracket.
h. Cut the System Handle free of the Actuation Catheter.
End Cap Suturing Arm
i. Back feed the End Cap’s Actuation Catheter and the
Stuck Open
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.
Current Condition Steps to Resolve Condition
First line of defense:
1. Ensure the System Handle is shuttled all of the way out
2. Open the System Handle by squeezing the Handle Grip – ensure
the Handle Grip Lock is disengaged
End Cap Suturing Arm 3. Gently steer the endoscope tip to allow the End Cap to open naturally
is Stuck in Tissue Severe Entrapment:
Eject the End Cap and remove by the following means:
1. Follow the instructions on the prior section to insert an overtube
and advance it to the End Cap.
2. Once the End Cap is visible through the endoscope, separate the
End Cap assembly from the tissue using standard endoscopic
techniques.
3. Pull the End Cap into the overtube and remove using standard
endoscopic techniques.
Current Condition Steps to Resolve Condition
1. Pass a compatible grasper down the secondary channel and
grasp the Suture. While holding the graspers on the Suture, pull
the Cinch out of the endoscope and the System Handle. If the
Cinch cannot be removed from the system, continue to step 2.
2. Regardless of the location of the Cinch, ensure that Cinch has
Suture Cinch is stuck
been fully deployed. If not, deploy the Cinch per the “Cinching”
on the Suture
section of the IFU. If the Cinch cannot be removed from the system
after deployment, continue to step 3.
3. Remove any accessory from the endoscope’s secondary channel
and pass the compatible loop cutter down the secondary channel.
Use the loop cutter to cut the Suture between the surgical site and
the Cinch. This will free the system for removal.
19

20. Description Symbol Description Symbol
Consult instructions for use Caution
Consult accompanying
documents
Usage Restriction Do Not Resterilize
(Single Use Only / Do Not Reuse)
Sterile Expiration Date
(Sterilized Using Ethylene Oxide)
Catalog Number Lot Number
Manufactured By Do not use if package has
been opened or damaged
Caution
Federal law restricts this device
to sale by or on the order of a
(licensed healthcare practitioner)
Apollo Endosurgery, Inc.
7000 Bee Caves Road, Suite 350
Austin, Texas 78746
Copyright ©2010 Apollo Endosurgery, Inc. All rights reserved. GRF-00002-00R04