MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. OPT SLEEVE 5X100MM STABILITY; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number	2CB5LT
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/14/2019
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.
Event or Problem Description
It was reported that during a lap appendectomy, the trocar was damaged.At the very distal end of the trocar, right at the end effector, there is a piece of the clear cannula that was missing.It is unknown if it broke off or was manufactured this way.There was no piece found.Case completed with the same trocar there were no patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Additional information: photos were received from customer for review.Upon visual inspection of three photos, the following was observed: the first photo shows a sleeve inside of a plastic bag and lot number can be seen as #t40m22 and product code is 2cb5lt.The second and third photo shows the distal end of sleeve inside of a plastic bag and damage appears to be observed at the distal end of the trocar.However, the photos are not clear.Based on review of the photos, the event described is confirmed, however no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.

• Brand Name: OPT SLEEVE 5X100MM STABILITY
• Common Device Name: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9299016
• Report Number: 3005075853-2019-23405
• Device Sequence Number: 16714987
• Product Code: GCJ
• UDI-Device Identifier: 10705036013730
• UDI-Public: 10705036013730
• Combination Product (Y/N): N
• PMA/510(K) Number: K032676
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2019

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: 06/30/2024
• Device Catalogue Number: 2CB5LT
• Device Lot Number: T40M2Z
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/21/2019
• Supplement Date Received by Manufacturer: 10/29/2019
• Initial Report FDA Received Date: 11/08/2019
• Supplement Report FDA Received Date: 11/20/2019
• Patient Sequence Number: 1