FDA Adverse Event
Malfunction
Summary report: N
MIRCO OSCILLATING SAW
MDR report key: 2241552
·
Received September 2, 2011
Report
- Report Number
- 1811755-2011-03256
- Event Type
- Malfunction
- Date Received
- September 2, 2011
- Date of Event
- August 9, 2011
- Report Date
- August 9, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- HBE
- PMA / PMN Number
- K032303
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CORROSION WAS NOTED THROUGHT THE INTERNAL COMPONENTS OF THE DEVICE.
Description of Event or Problem · 1
THE MICRO OSCILLATING SAW WAS SENT IN FOR SERVICE AND IT RAN IN THE SAFE MODE WHEN THE CABLE WAS FLEXED DURING PERFORMANCE TESTING. NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MIRCO OSCILLATING SAW | HBE | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |