FDA Adverse Event Injury Summary report: N

ETHICON 10MM LIGACLIP

MDR report key: 3040026 · Received April 2, 2013

Report

Report Number
MW5029611
Event Type
Injury
Date Received
April 2, 2013
Date of Event
February 26, 2013
Report Date
March 21, 2013
Manufacturer
ETHICON - ENDO SURGERY INC.
Product Code
FZP
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
MD, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

A 5MM LAPAROSCOPIC CLIP APPLIER WAS BEING USED FOR A LAPAROSCOPIC CHOLECYSTECTOMY. CLIP APPLIER FIRED; CLIP WAS TOO LOOSE TO SEAL VESSEL.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
134906 ETHICON 10MM LIGACLIP LIGACLIP FZP ETHICON - ENDO SURGERY INC. J4CV48

Patients

Seq Age Sex Outcome Treatment
1 46 YR Required Intervention