MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. OPT BLADELESS 5X75 STABILITY; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number	2B5ST
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: the analysis results found that the 2b5st device was received with the tip of the sleeve melted.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.One possible cause for this type of damage may be interaction with an energized device used during the procedure.Caution should be taken to avoid contact between an energized device and the trocar during the surgical procedure.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformance's were identified.
Additional Manufacturer Narrative
(b)(4).Batch # t9480e.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.
Event or Problem Description
It was reported that during a laparoscopic bladder total extirpation, the outer sleeve of the 2b5st trocar was deformed during use.There was a possibility that the outer sleeve touched the a probe plus.Another device was used to complete the case.There were no adverse consequence to the patient.No further information is available.

• Brand Name: OPT BLADELESS 5X75 STABILITY
• Common Device Name: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9331224
• Report Number: 3005075853-2019-23526
• Device Sequence Number: 1960581
• Product Code: GCJ
• UDI-Device Identifier: 10705036013716
• UDI-Public: 10705036013716
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2019

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: 07/22/2024
• Device Catalogue Number: 2B5ST
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2019
• Initial Date Received by Manufacturer: 10/24/2019
• Supplement Date Received by Manufacturer: 11/26/2019
• Initial Report FDA Received Date: 11/15/2019
• Supplement Report FDA Received Date: 12/17/2019
• Patient Sequence Number: 1