MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENSEAL 5MM ROUND TIP 45 CM; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	NSEAL545RH
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.Mw5076139.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.
Event or Problem Description
It was reported that during an unknown procedure; ¿while dividing this thickened omental adhesion, i noticed that the device was not functioning properly and further inspection revealed that one of the jaws was broken.I tried to remove the device but, unfortunately, the broken jaw did not come out and we thought it had got into the peritoneal cavity.At this point, i called for fluoroscopy to help with locating the metal piece which is a portion of the jaw of the device, which was missing from the instrument.Using fluoroscopy, the entire abdomen was scanned and we did not find anything in the abdomen and finally when we scanned the trocars, the small metal piece was lodged in one of the trocars in the left flank.I then removed the trocars and retrieved the metal piece out of the trocar.The trocar was then replaced and we proceeded with the rest of our operation.The omental adhesions were taken down with another new device.¿ there were no patient consequences reported.

• Brand Name: ENSEAL 5MM ROUND TIP 45 CM
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7471999
• Report Number: 3005075853-2018-09408
• Device Sequence Number: 13940521
• Product Code: GEI
• UDI-Device Identifier: 20705036000058
• UDI-Public: 20705036000058
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K072493
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/09/2018

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: 12/31/2019
• Device Catalogue Number: NSEAL545RH
• Device Lot Number: R9244A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/09/2018
• Initial Report FDA Received Date: 04/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1