POWERPRO ELECTRIC II OSCILLATOR HANDPIECE
Received Jan 9, 2008 · Event occurred Dec 14, 2007
Report 1017294-2008-00023 · MDR key 981212
Device
Generic name
Oscillating Saw
Manufacturer
Conmed LinvatecModel number
UNKCatalog number
PRO6125
Lot number
NA
Product problems
- Out-Of-Box Failure
Patient
NA
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE DISTRIBUTOR RETURNED THIS DEVICE WITH A REQUEST FOR EVALUATION/REPAIR BECAUSE A PROBLEM WAS NOTED DURING PRE-TESTING OF THE DEVICE. THERE WAS NO REPORT OF SERIOUS INJURY OR SURGICAL DELAY WITH THIS EVENT.
Additional Manufacturer Narrative
INVESTIGATION FINDINGS: CONMED LINVATEC RECEIVED THIS DEVICE FOR EVALUATION AND DURING TESTING FOUND THAT THE HANDPIECE HAS THE POTENTIAL TO OPERATE IN SAFE MODE WITHOUT DEPRESSING THE TRIGGER. THIS OCCURS WHEN THE DEVICE IS FIRST CONNECTED TO THE CONSOLE. FURTHER INVESTIGATION FOUND MOISTURE PRESENT INSIDE THE HANDPIECE WITH CORROSIVE DEPOSITS THAT CAUSED FAILURE OF THE PC BOARD. CONMED LINVATEC WILL CONTINUE TO MONITOR THIS PRODUCT FOR FAILURES.