apollo endosurgery OverStitch Sx Gebrauchsanweisung Seite 10

13.3.3 Anchor Exchange will not retrieve Anchor from
Needle Body:
13.4. Cinch does not cut the Suture when fired:
Cause
13.4.1. Suture not cut:
13.5. Inadvertent drop of Anchor:
Cause
13.5.1. Anchor Exchange button depressed out of sequence:
13.6. Suture entanglement:
Cause
13.6.1. Suture outside field of view:
13.6.2. Suture behind Tissue Guard:
13.6.3. Suture twisted:
13.7 . Endcap detachment from endoscope:
Cause
13.7 .1. Detached during use:
13.8. Helix does not unscrew:
Cause
13.8.1. Helix stuck in tissue:
13.9. Endcap Strap end is not seated in Endcap prior to cutting Endcap Strap Tails:
Cause
13.9.1. Endcap Clip Hinge not fully pushed in during
installation:
13.10. Difficulty passing installed device through overtube:
Cause
13.10.1. Insufficient lubricant applied:
13.10.2. Endoscope and/or overtube sizing not compatible:
13.10.3. Catheters are not flat against scope:
13.10.4. Endcap Straps not trimmed flush with Endcap:
i. Ensure there is sufficient Suture slack and Needle Driver handle is in closed position.
ii. Use 'pencil-grip' to advance Anchor Exchange until the Anchor is engaged and resistance is felt. Retract Anchor
Exchange to acquire Anchor.
iii. If the Anchor cannot be retrieved, replace the Anchor Exchange. Alternatively, use a suitable accessory to cut
and remove the Suture.
iv. Replace the Anchor and resume suturing per Section 8 of Instructions for Use.
Resolution
i. Use a suitable accessory through the device secondary channel or endoscope working channel to cut the
Suture and remove the Cinch.
ii. Use standard endoscopic techniques to remove the cut Suture.
Resolution
i. Retrieve the Anchor as a foreign body, or follow the procedure to Cinch in place. If the Anchor is dropped inside
the device channel, use the Anchor Exchange or 3.2 mm compatible grasper to push the Anchor out through the device.
Do not attempt to pull the Anchor back through the device as it may get stuck in the channel or y-junction at the handle.
Resolution
i. Close the Needle Driver Handle and manipulate the endoscope back to release.
i. Slightly close the Needle Body while retracting the endoscope.
ii. If necessary, transfer the Anchor to the Anchor Exchange.
iii. Open the Needle Body and advance the Anchor Exchange beyond the Endcap to push the Suture free.
i. If the Suture is twisted, move the endoscope and transfer the Anchor between the Needle Body and Anchor
Exchange, on the opposite side of the suture thread, as needed to untwist.
NOTE: If the twist was noted immediately after articulation of the endoscope, first try to articulate in reverse
order to remove.
ii. If the Anchor has been deployed, use the Cinch to push and guide the Suture free.
Resolution
i. Close the Needle Body, remove any slack in Actuation Catheter and slowly remove the device from the patient.
If using an overtube, advance the overtube as far distally as possible and withdraw the endoscope and device
into the overtube, maintaining tight hold of the Sheath to keep the Endcap flush with the endoscope.
Resolution
i. Use a suitable accessory through the device primary channel or endoscope working channel to apply counter
traction to the tissue around the Helix, and pull the Helix free.
ii. Once endoscopic techniques have been exhausted, utilize laparoscopic techniques to remove the Helix.
Resolution
i. Gently pull on the endoscope to fully recess non-tail end of both Endcap Straps within Endcap
ii. If not discarded, thread Endcap Strap tails through the corresponding channel slots 1 and 2 in Endcap Clip. Re-
fit Endcap Clip with a clockwise rotation onto Endcap (opposite of section 4.16) and repeat assembly steps.
iii. If Endcap Clip is not available, use left thumb in place of the Endcap Clip to hold the non-tail end of each
Endcap Strap within Endcap and repeat Endcap Strap tightening steps.
Resolution
i. Fully lubricate device and inside of overtube. Apply a twisting motion of the endoscope with the installed
device during intubating and extubating.
i. Exchange overtube selected with a larger sized overtube.
i. Maneuver the scope and device to lay flat against each other. Apply a twisting motion of the endoscope with
the installed device during intubating and extubating.
i. Remove endoscope from overtube. Trim Endcap Straps flush with Endcap per Step 4.18.
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