FDA Adverse Event
Malfunction
Summary report: N
TPS HANDPIECE CORD
MDR report key: 2851286
·
Received October 29, 2012
Report
- Report Number
- 1811755-2012-03954
- Event Type
- Malfunction
- Date Received
- October 29, 2012
- Date of Event
- October 15, 2012
- Report Date
- October 15, 2012
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- HRX
- PMA / PMN Number
- K943323
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
A TPS HANDPIECE CORD WAS SENT FOR EVALUATION BECAUSE IT WAS CAUSING HANDPIECE CORD WAS SENT FOR EVALUATION BECAUSE IT 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 | 11138 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |