FDA Adverse Event
Malfunction
Summary report: N
MICRO OSCILLATING SAW
MDR report key: 2853983
·
Received October 24, 2012
Report
- Report Number
- 1811755-2012-03884
- Event Type
- Malfunction
- Date Received
- October 24, 2012
- Date of Event
- September 24, 2012
- Report Date
- September 24, 2012
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- HBE
- PMA / PMN Number
- K032303
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
CORROSION WAS DISCOVERED WITHIN INTERNAL COMPONENTS OF THE DEVICE.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A ROUTINE EQUIPMENT EVAL BY A MANUFACTURER'S SERVICE TECHNICIAN THAT THE MICRO OSCILLATING SAW DISPLAYED A BIAS CURRENT ERROR WHEN CONNECTED TO THE CONSOLE, SIGNALING A RUN-ON CONDITION OCCURRED. THERE WAS NO PT INVOLVEMENT, AND THERE WERE NO USER INJURIES OR ADVERSE CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MICRO OSCILLATING SAW | HBE | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |