FDA Adverse Event
Malfunction
Summary report: N
REPAIR TPS OSC SAW
MDR report key: 1903056
·
Received November 12, 2010
Report
- Report Number
- 1811755-2010-01696
- Event Type
- Malfunction
- Date Received
- November 12, 2010
- Date of Event
- October 18, 2010
- Report Date
- October 18, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- HBE
- PMA / PMN Number
- K032303
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE HANDPIECE WAS RECEIVED AT THE MFR FOR EVAL, AND THE REPORTED CONDITION OF THE DEVICE RUNNING ON ITS OWN WAS DUPLICATED. BASED ON THE INVESTIGATION DETAILS, THE LIKELY CAUSE WAS CORROSION ON THE MOTOR, WHICH WAS REPLACED ALONG WITH OTHER COMPONENTS. SERVICE DID A CLEAN, LUBE, AND ADJUSTMENT TO THE DEVICE, AND IT WAS REPAIRED AND RETURNED TO THE CUSTOMER.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE HANDPIECE WAS RUNNING ON ITS OWN. IT IS UNK IF THERE WAS PT INVOLVEMENT OR ANY ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. ADDITIONAL INFO WAS REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REPAIR TPS OSC SAW | SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTAC | HBE | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |