FDA Adverse Event Summary report: N

LIGACLIP

MDR report key: 2092143 · Received May 4, 2011

Report

Report Number
2092143
Date Received
May 4, 2011
Date of Event
April 11, 2011
Report Date
May 2, 2011
Manufacturer
ETHICON ENDO
Product Code
FZP
Report Source
User Facility report
Reporter Location
CA, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

LIGACLIP OPEN FOR A GASTRIC BYPASS. THE SCRUB NURSE CHECKED THE CLIP AND NOTICED REFILL CLIP WAS SLOW TO RELOAD. LIGACLIP REMOVED FROM FIELD AND REPLACED WITH A NEW LIGACLIP.======================MANUFACTURER RESPONSE FOR LIGACLIP, LIGACLIP (PER SITE REPORTER)======================NO RESPONSE AT THIS TIME.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 LIGACLIP CLIP APPLIER FZP ETHICON ENDO ER420 #F4PJ2U

Patients

Seq Age Sex Outcome Treatment
1 *