FDA Adverse Event Summary report: N

LIGACLIP

MDR report key: 3232381 · Received July 8, 2013

Report

Report Number
3232381
Date Received
July 8, 2013
Report Date
July 8, 2013
Manufacturer
ETHICON ENDO-SURGERY, INC.
Product Code
FZP
Report Source
User Facility report
Reporter Location
CA, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

LIGACLIPS FIRED BY SURGEON: CLIPS NOT CLOSING ACROSS VESSEL COMPLETELY TO OCCLUDE. FIRED MULTIPLE CLIPS AND NONE FIRED CLOSED CORRECTLY.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?NA.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
310915 LIGACLIP CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, INC. * K4CG21

Patients

Seq Age Sex Outcome Treatment
1 49 YR