• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON ETHICON CLIP GUN

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ETHICON ETHICON CLIP GUN Back to Search Results
Catalog Number ER420
Event Date 04/18/2016
Event Type  Malfunction  
Event Description

Intra-operatively, after the cystic duct was clipped proximally and distally and then transected, it was noted that the clips started to migrate off of the duct. They were removed and this was inspected. The duct was grasped and another clip was placed. This scissored and it was soon apparent that the other two clips and scissored as well. Surgeon attempted to control this with a non-disposable clip applier, was unable to get these to seed as they would not clip tight enough, and eventually changed guns and got another disposable extra-long clip applier. Eventually able to get a single clip across cystic duct where there was no leakage of bile. Irrigated, inspected, no leakage of bile noted at cystic duct.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameETHICON CLIP GUN
Type of DeviceETHICON CLIP GUN
Manufacturer (Section D)
ETHICON
MDR Report Key5608460
Report NumberMW5061877
Device Sequence Number1
Product CodeFZP
Report Source Voluntary
Reporter Occupation Nurse
Report Date 04/21/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/21/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberER420
Device LOT NumberM91U68
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 04/21/2016 Patient Sequence Number: 1
-
-