MAUDE Adverse Event Report: ETHICON ETHICON CLIP GUN

Catalog Number ER420

Device Problems Migration or Expulsion of Device (1395); Cut In Material (2454); Failure to Form Staple (2579)

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

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.

• Brand Name: ETHICON CLIP GUN
• Type of Device: ETHICON CLIP GUN
• Manufacturer (Section D): ETHICON
• MDR Report Key: 5608460
• MDR Text Key: 43771121
• Report Number: MW5061877
• Device Sequence Number: 1
• Product Code: FZP
• 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: 04/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ER420
• Device Lot Number: M91U68
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27 YR
• Patient Weight: 113