FDA Adverse Event
Malfunction
Summary report: N
MICRO OSCILLATING SAW
MDR report key: 3022944
·
Received March 27, 2013
Report
- Report Number
- 0001811755-2013-00609
- Event Type
- Malfunction
- Date Received
- March 27, 2013
- Date of Event
- February 28, 2013
- Report Date
- February 28, 2013
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- ERL
- PMA / PMN Number
- K040300
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
UPON DISASSEMBLY, CORROSION WAS FOUND IN THE MOTOR, PRESS PLUG, AND DRIVER.
Description of Event or Problem · 1
THE MICRO OSCILLATING SAW WAS RETURNED FOR SERVICE. UPON EVALUATION AT THE MANUFACTURER, IT WAS FOUND TO RUN WITHOUT USER ACTIVATION. THERE WAS NO PATIENT INVOLVEMENT, AND THERE WERE NO USER INJURIES OR ADVERSE CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 126435 | MICRO OSCILLATING SAW | DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE | ERL | STRYKER INSTRUMENTS-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |