FDA Adverse Event
Malfunction
Summary report: N
REPAIR CORE RECIP SAW
MDR report key: 1935153
·
Received December 6, 2010
Report
- Report Number
- 1811755-2010-01910
- Event Type
- Malfunction
- Date Received
- December 6, 2010
- Date of Event
- November 15, 2010
- Report Date
- November 15, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- HBE
- PMA / PMN Number
- K032303
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE HANDPIECE WAS RECEIVED AT THE MANUFACTURER FOR TESTING. AN EVALUATION WILL BE CONDUCTED, AND A FOLLOW-UP REPORT WILL BE SUBMITTED IF THE RESULTS OF THE QUALITY INVESTIGATION REQUIRE ONE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE HANDPIECE IS LEAKING BLACK OIL. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REPAIR CORE RECIP SAW | SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTAC | HBE | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |