MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH*BLUNT CHERRY DISSECT; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Catalog Number	BCD10
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk additional information received: a photo was received for review, and upon visual inspection of a photo, the following was observed: the photo shows the tip of the dissector from top view and the cotton were observed to be detached.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.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.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 an unknown procedure, product had split into pieces.All pieces of product have been removed from patient body.To complete procedure, physician used another product of the same type.Patient consequence was not reported.
Additional Manufacturer Narrative
(b)(4).Additional information received: unfortunately, despite multiple attempts customer didn`t provide any additional details (regarding additional information that was requested).See additional information that was requested below.Attempts have been made to obtain the following information: what procedure were they performing? was there any patient consequence? if yes: please explain? how was the patient consequence resolved? which lot number belongs to the reported device, r4143g or r4047e.To date, no response has been provided.If the device or further details are received at a later date, a supplemental medwatch will be sent.Corrected data: lot number could be r4143g or r4047e.Customer was unable to confirm.A manufacturing record evaluation was performed for the finished device lot numbers r4143g and r4047e and no non-conformances were identified.

• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9125529
• Report Number: 3005075853-2019-22362
• Device Sequence Number: 380501
• Product Code: MDM
• UDI-Device Identifier: 10705036011866
• UDI-Public: 10705036011866
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• 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): 09/05/2019

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: 01/31/2023
• Device Catalogue Number: BCD10
• Device Lot Number: R4047E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/05/2019
• Supplement Date Received by Manufacturer: 09/10/2019
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 09/26/2019
• Patient Sequence Number: 1