FDA Adverse Event
Malfunction
Summary report: N
TPS HANDPIECE CORD
MDR report key: 2974613
·
Received January 17, 2013
Report
- Report Number
- 1811755-2013-90116
- Event Type
- Malfunction
- Date Received
- January 17, 2013
- Date of Event
- December 4, 2012
- Report Date
- December 4, 2012
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- HRX
- PMA / PMN Number
- K943323
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVAL IS ON-GOING; ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE DEVICE EVAL IS COMPLETE.
Description of Event or Problem · 1
A TPS HANDPIECE CORD WAS SENT FOR SERVICE AND BIAS CURRENT WAS EXPERIENCED DURING PERFORMANCE TESTING. THE BIAS CURRENT ERROR MESSAGE SIGNALS A POTENTIAL TO CAUSE A HANDPIECE TO RUN WITHOUT USER ACTIVATION. NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 27320 | TPS HANDPIECE CORD | HRX | STRYKER INSTRUMENTS KALAMAZOO | 12016 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |