MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. OPT SLEEVE 12X100 STABILITY; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Model Number	2CB12LT
Medical Device Problem Codes	Material Separation (1562); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/24/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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.

• Brand Name: OPT SLEEVE 12X100 STABILITY
• Common Device Name: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 10532727
• Report Number: 3005075853-2020-04675
• Device Sequence Number: 2902606
• Product Code: GCJ
• UDI-Device Identifier: 10705036014263
• UDI-Public: 10705036014263
• Combination Product (Y/N): N
• PMA/510(K) Number: K122512
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2020
• Device Model Number: 2CB12LT
• Device Catalogue Number: 2CB12LT
• Device Lot Number: U4070L
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/24/2020
• Supplement Date Received by Manufacturer: 12/21/2020
• Initial Report FDA Received Date: 09/14/2020
• Supplement Report FDA Received Date: 01/13/2021
• Patient Sequence Number: 1