MalfunctionEXX
ROTO-LOK HUNTER GRASPER 3.5 X 24
Received Dec 7, 2010
Report 2523190-2010-00018 · MDR key 1950091
Device
Generic name
None
Catalog number
630164
Product problems
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE CUSTOMER REPORTS THE JAW BROKE DURING A LAPAROSCOPIC CHOLECYSTECTOMY WHILE GRASPING A HARD GALLBLADDER. IT APPEARED TO THE CUSTOMER THAT NO PARTS WERE DETACHED. NO PT INJURY.
Additional Manufacturer Narrative
TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.