ETHICON ENDO-SURGERY, LLC. OPT SLEEVE 12X100 STABILITY; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
|
Back to Search Results |
|
Model Number 2CB12LT |
Device Problems
Material Separation (1562); Gas/Air Leak (2946)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 08/24/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).Batch # unk.A manufacturing record evaluation was performed for the finished device lot number and no non-conformances were identified.As the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.Additional information: a photo was received for review.The review is still in progress and has not yet been completed.Once the review has been completed, this additional information will be submitted in a supplemental medwatch.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
|
|
Event Description
|
It was reported that during a sleeve gastrectomy surgery, the trocar leaked.When checked, it could be seen that it was loose and separated into two parts.Surgery was delayed by twenty minutes however no fragments were generated, the procedure was successfully completed, and there was no patient consequence.
|
|
Manufacturer Narrative
|
(b)(4).Date sent: 1/13/2021.H2: additional information received: a photo was received for review.Upon visual inspection of one photo, the following was observed: the photo shows the universal seal disassembled in two pieces on the hands of user.Based on the photo, the event described is confirmed, however no conclusion or root cause could be determined.Hands on device analysis may have provided the additional evidence necessary to confirm the root cause of the reported event, however, as the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.
|
|
Search Alerts/Recalls
|
|
|