FDA Adverse Event
Malfunction
Summary report: N
REPAIR TPS OSC SAW
MDR report key: 1505237
·
Received September 22, 2009
Report
- Report Number
- 1811755-2009-00554
- Event Type
- Malfunction
- Date Received
- September 22, 2009
- Date of Event
- August 24, 2009
- Report Date
- August 24, 2009
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- DZH
- PMA / PMN Number
- K040300
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN RECEIVED AT THE MANUFACTURER, AND A QUALITY EVALUATION WILL BE CONDUCTED. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT BEFORE A SURGICAL PROCEDURE, A BLACK FLUID CAME OUT OF THE DEVICE. THERE WAS NO REPORTED PT OR USER INJURY, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER DEVICE THAT WAS ON HAND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REPAIR TPS OSC SAW | SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTAC | DZH | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |