MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH*5MM BABCOCK GRASPER; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Catalog Number	5BB
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # t93e89.Investigation summary: the analysis result found that the 5bb instrument was returned with the grasper shaft misaligned.No functional testing could be performed due to the condition of the device.It is possible that the damage was due to an improper handling of the device.A manufacturing record evaluation was performed for the finished device lot/batch number, and no non-conformances were identified.
Event or Problem Description
It was reported that during an unknown procedure, as the surgeon attempted to grasp the eea sizer, the end of the babcock broke off.The procedure was completed with another like device with no patient consequences reported.

• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9448693
• Report Number: 3005075853-2019-24161
• Device Sequence Number: 19686676
• Product Code: MDM
• UDI-Device Identifier: 10705036000761
• UDI-Public: 10705036000761
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/15/2019

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: 04/30/2024
• Device Catalogue Number: 5BB
• Device Lot Number: T40H94
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2019
• Initial Report FDA Received Date: 12/10/2019
• Patient Sequence Number: 1