D
Patient 1
IT WAS REPORTED THAT THIS HANDPIECE WOULD CONTINUE TO RUN AFTER RELEASE OF THE TRIGGER. THERE WAS NO REPORT OF INJURY OR SURGICAL DELAY ASSOCIATED WITH THIS EVENT.
MAUDE MDR 946646
- MDR report key
- 946646
- Report number
- 1017294-2007-00776
- Event key
- 0
- Event type
- 3
- Date of event
- 2007-10-09
- Date received
- 2007-11-07
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- BEVERLY SCHANER
- Address
- 11311 CONCEPT BLVD. LARGO FL 33773 US
- Phone
- 727-727-7273
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | MPOWER TWO TRIGGER MODULAR HANDPIECE | BATTERY HANDPIECE | CONMED LINVATEC | FCO | NA | PRO6202 | NA | N | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2007-11-07 | 0 |
Event Narratives#
N
Patient 1
INVESTIGATION RESULTS: AN EVAL CONFIRMED THE REPORTED PROBLEM THAT THE HANDPIECE WOULD CONTINUE TO RUN AFTER RELEASE OF THE TRIGGER. FURTHER INVESTIGATION FOUND THAT THIS HANDPIECE HAS THE POTENTIAL TO OPERATE IN THE SAFE MODE RELATED TO CONTROLLER FAILURE. AN INVESTIGATION FOR THIS FAILURE MODE REMAINS IN PROCESS. CONMED LINVATEC WILL CONTINUE TO MONITOR THIS DEVICE FOR FAILURES.