FDA Adverse Event Malfunction Summary report: N

ENDO CATCH GOLD

MDR report key: 4131329 · Received September 15, 2014

Report

Report Number
4131329
Event Type
Malfunction
Date Received
September 15, 2014
Date of Event
September 11, 2014
Report Date
September 15, 2014
Manufacturer
COVIDIEN LP
Product Code
GCJ
Product Problem
Yes
Report Source
User Facility report
Reporter Location
VA, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

WHILE USING THE ENDOCATCH TO REMOVE THE GALLBLADDER, THE HANDLE OF THE CATCH BROKE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
569329 ENDO CATCH GOLD LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ COVIDIEN LP 173050G J4F0013MX

Patients

Seq Age Sex Outcome Treatment
1 43 YR