FDA Adverse Event
Malfunction
Summary report: N
TPS HANDPIECE CORD
MDR report key: 3950096
·
Received July 22, 2014
Report
- Report Number
- 0001811755-2014-02611
- Event Type
- Malfunction
- Date Received
- July 22, 2014
- Date of Event
- July 3, 2014
- Report Date
- July 3, 2014
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- DZJ
- PMA / PMN Number
- K943540
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DURING THE DEVICE EVALUATION, THE TECHNICIAN DETERMINED THE CABLE¿S INTERNAL WIRING WAS DAMAGED. THE DEVICE WILL BE DISCARDED BY THE MANUFACTURER.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE MANUFACTURER FACILITY THE TPS HANDPIECE CORD CAUSED A BIAS CURRENT MESSAGE TO BE DISPLAYED ON THE CONSOLE, SIGNALING A CONDITION OCCURRED IN WHICH THE DEVICE HAS THE POTENTIAL TO RUN WITHOUT USER ACTIVATION. IT WAS REPORTED THAT THERE WAS NO ASSOCIATED PROCEDURE. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 428930 | TPS HANDPIECE CORD | DRIVER, WIRE, AND BONE DRILL, MANUAL | DZJ | STRYKER INSTRUMENTS-KALAMAZOO | 12041 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |