FDA Adverse Event
Malfunction
Summary report: N
MICRO OSCILLATING SAW
MDR report key: 2042871
·
Received March 30, 2011
Report
- Report Number
- 1811755-2011-01035
- Event Type
- Malfunction
- Date Received
- March 30, 2011
- Date of Event
- March 2, 2011
- Report Date
- March 2, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- HBE
- PMA / PMN Number
- K032303
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RECEIVED FOR EVAL; ADD'L INFO WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
A STRYKER MICRO OSCILLATING SAW WAS CALLED IN FOR REPAIR DUE TO OVERHEATING DURING REGULAR MAINTENANCE CHECK. THERE WAS NO PT INVOLVEMENT; NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.
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 |