FDA Adverse Event Injury Summary report: N

ETHICON

MDR report key: 1698622 · Received May 20, 2010

Report

Report Number
MW5016050
Event Type
Injury
Date Received
May 20, 2010
Date of Event
May 7, 2010
Report Date
May 20, 2010
Manufacturer
CQ LABS
Product Code
LFL
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
MO, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

DURING A GASTRIC BANDING LAPAROSCOPIC SURGERY, REPROCESSED HARMONIC ACE SHEARS STOPPED WORKING IN THE MIDDLE OF THE SURGERY. NEW HARMONIC SHEARS WERE OPENED AND USED TO COMPLETE THE SURGERY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 ETHICON HARMONIC ACE SHEARS LFL CQ LABS ACE36E 1008987

Patients

Seq Age Sex Outcome Treatment
1 39 YR Disability