FDA Adverse Event Injury Summary report: N

LIGAMAX 5

MDR report key: 1639110 · Received March 19, 2010

Report

Report Number
MW5015247
Event Type
Injury
Date Received
March 19, 2010
Date of Event
March 8, 2010
Report Date
March 19, 2010
Manufacturer
CQ LABS
Product Code
GDO
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
MO, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE APPLIER BROKE. THE JAW WOULD NOT CLOSE AND IT WOULD NOT APPLY A CLIP PROPERLY. THIS OCCURRED AFTER CLIPPING VESSELS. THERE WAS NO PT INJURY AND THE CASE CONTINUED AS NORMAL.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 LIGAMAX 5 ENDOSCOPIC APPLIER GDO CQ LABS EL5ML GSR80L

Patients

Seq Age Sex Outcome Treatment
1 37 YR Disability