MalfunctionDWH
MPOWER SMALL BATTERY OSCILLATING SAW
Received Jan 28, 2008
Report 1017294-2008-00095 · MDR key 991435
Device
Generic name
Oscillating Saw
Manufacturer
Conmed LinvatecModel number
NACatalog number
PRO6300
Lot number
NA
Product problems
- Device Remains Activated
Patient
UNK
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT DURING USE OF THIS HANDPIECE, IT WOULD NOT SHUT OFF. THERE WAS NO REPORT OF SERIOUS INJURY OR SURGICAL DELAY WITH THIS EVENT.
Additional Manufacturer Narrative
INVESTIGATION FINDINGS: CONMED LINVATEC RECEIVED THIS HANDPIECE FOR EVALUATION. DURING TESTING, THE EVALUATOR FOUND THIS DEVICE HAS THE POTENTIAL TO OPERATE ON ITS OWN RELATED TO CONTROLLER FAILURE. AN INVESTIGATION INTO THIS FAILURE MODE REMAINS IN PROCESS. CONMED LINVATEC WILL CONTINUE TO MONITOR THIS DEVICE FOR FAILURES.