Troubleshooting - apollo endosurgery OverStitch Sx Gebrauchsanweisung

12. MRI Information
MR Conditional
Non-clinical testing has demonstrated that the
Sutures, Cinches and Anchors (collectively termed
Anchoring System) deployed by the OverStitch
Endoscopic Suturing System are MR Conditional.

13. Troubleshooting

13.1. Needle Body will not open:
Cause
13.1.1. Needle obstructed:
13.1.2. Suture movement restricted:
13.1.3. Sheath or Actuation Catheter looped or kinked:
13.1.4. Foreign body obstruction:
13.2. Needle Body will not close:
Cause
13.2.1. General obstruction:
13.2.2. Needle Driver cable broken:
13.3. Anchor Exchange will not exchange:
Cause
13.3.1. Anchor Exchange will not install Anchor onto the
Needle Body:
13.3.2. Anchor Exchange will not release an Anchor:
A patient with this Anchoring System can be safely
scanned immediately after placement in an MR
system meeting the following conditions:
- Static magnetic field of 1.5 T or 3.0 T
- Maximum spatial field gradient of 2,000 gauss/cm
(20 T/m)
- Maximum MR system reported, whole body
averaged specific absorption rate (SAR) of 2 W/kg
Resolution
i. Assess the space in which you are working and maneuver the Sheath and endoscope as a system, straighten
the endoscope to the non-Retroflexed position.
i. If the Anchor is on the Needle Body, ensure the suture is not held proximally near the handle during the
opening operation.
ii.Transfer the Anchor to the Anchor Exchange. Open the Needle Body. Slowly retract the Anchor Exchange
proximally and then advance the Needle Body distally to free the Suture.
i. Check to ensure that the Sheath and Actuation Catheter running down the outside of the endoscope are not
looped or kinked. Straighten the endoscope to the non-Retroflexed position. Advance the endoscope forward and
slightly pull any slack from the Sheath and Actuation Catheter proximally until minimal resistance is felt. Grasp
both the Sheath and endoscope and adjust by advancing and retracting as a system.
i. Remove the Anchor Exchange only:
a. Transfer the Anchor to the Needle Body and remove the Anchor Exchange from the device.
b. Load a grasper through the primary channel and push the Needle Body open.
ii. Remove the Anchor and Anchor Exchange, cutting the Suture if necessary:
a. Transfer the Anchor to the Needle Body and remove the Anchor Exchange from the device.
b. Through either channel use an appropriate accessory to cut the Suture.
c. Use an accessory to push open the Needle Body
d. Use appropriate means to remove the cut Suture.
iii. Once standard endoscopic techniques have been exhausted, utilize laparoscopic techniques to remove the
device.
Resolution
i. Follow steps 13.1.1, 13.1.2, 13.1.3 above (Needle Body will not open).
ii. Ensure the Needle Driver handle is locked closed and:
a. Stretch the Actuation Catheter to change the effective length of the Needle Body drive cable.
b. Remove the Anchor Exchange and use graspers (through the device primary channel) to grab the Needle
Body. Cut the Suture if necessary.
i. Deploy the Anchor and Cinch. Advance grasper through endoscope and secure Needle Driver. Pull Needle
Driver closed while removing the device. If using an overtube, advance the overtube as far distally as possible
and withdraw the endoscope and device into the overtube, using the distal tip of the overtube to close the
Needle Body.
Resolution
i. Ensure there is sufficient Suture slack and the Suture outside the device is not entangled.
ii. Ensure Anchor Exchange is properly positioned in Endcap of Needle Driver.
iii. If Anchor and Suture are through tissue, either drop Anchor and deploy Cinch per Section 9 of Instructions for
Use or drop Anchor and use a suitable accessory to cut and remove the Suture.
iv. If Anchor and Suture are not through tissue, close handle of Needle Driver. Remove device. Replace Anchor
and/or Anchor Exchange.
i. Ensure there is sufficient Suture slack and the Suture outside the device is not entangled.
ii. Ensure the Anchor Exchange Release Button is FULLY depressed while retracting Anchor Exchange.
iii. Reduce the articulation / tortuosity of the endoscope (if possible) and try to release the Anchor.
iv. Use accessories compatible with device secondary channel or endoscope working channel to cut and remove
the Suture.
v. Replace the Anchor Exchange.
9
Under the scan conditions defined above, the
Anchoring System is expected to produce a maximum
temperature rise of less than 2º C after 15 minutes of
continuous scanning.
In non-clinical testing, the image artifact caused by the
Anchoring System extends approximately 10 mm from
this device when imaged with a gradient echo pulse
sequence and a 3.0 T MRI system.