FDA Adverse Event
Malfunction
Summary report: N
TPS HANDPIECE CORD
MDR report key: 2941829
·
Received December 21, 2012
Report
- Report Number
- 1811755-2012-04301
- Event Type
- Malfunction
- Date Received
- December 21, 2012
- Date of Event
- December 5, 2012
- Report Date
- December 5, 2012
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- HRX
- PMA / PMN Number
- K943323
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
IT IS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE EVENT WITHOUT AN EVAL OF THE DEVICE. ADD'L INFO WILL BE SUBMITTED WHEN THE DEVICE IS RECEIVED AND EVALUATED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A TPS HANDPIECE CORD WAS CAUSING HANDPIECES TO RUN WITHOUT ACTIVATION. THE EVENT OCCURRED DURING A ROUTINE FIELD SERVICE MAINTENANCE VISIT; NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TPS HANDPIECE CORD | HRX | STRYKER INSTRUMENTS KALAMAZOO | 07073 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |