MAUDE Adverse Event Report: ETHICON ENDOSURGERY, LLC ENSEAL HANDPIECE

Model Number NSEAL545RH

Device Problems Break (1069); Detachment Of Device Component (1104); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/20/2018

Event Type  malfunction  

Event Description

While dividing this thickened omental adhesion, i noticed that the enseal 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 enseal 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 trocar 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 enseal device.

• Brand Name: ENSEAL HANDPIECE
• Type of Device: HANDPIECE
• Manufacturer (Section D): ETHICON ENDOSURGERY, LLC; 4545 creek rd. ; cincinnati OH 45242
• MDR Report Key: 7373111
• MDR Text Key: 103785337
• Report Number: MW5076139
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/23/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: NSEAL545RH
• Device Lot Number: R9244A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/26/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 45 YR
• Patient Weight: 132