FDA Adverse Event Injury Summary report: N

ETHICON -J&J- ARTICULATING ENDOSCOPIC LINEAR CUTTER

MDR report key: 2061330 · Received April 12, 2011

Report

Report Number
MW5020270
Event Type
Injury
Date Received
April 12, 2011
Date of Event
March 18, 2011
Report Date
April 12, 2011
Manufacturer
ETHICON ENDOMECHANICAL SURGICAL
Product Code
GDW
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
FL, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

ACCORDING TO THE SURGEON THE STAPLER MISFIRED AND WOULD NOT UNCLAMP. THE SURGEON HAD TO CUT THE STAPLER OFF THE BOWEL.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 ETHICON -J&J- ARTICULATING ENDOSCOPIC LINEAR CUTTER ECHELON 60 STAPLER GDW ETHICON ENDOMECHANICAL SURGICAL H43774

Patients

Seq Age Sex Outcome Treatment
1 65 YR Disability