FDA Adverse Event
Malfunction
Summary report: N
NAVIGATION SYSTEM II - CART
MDR report key: 2210647
·
Received July 26, 2011
Report
- Report Number
- 3007582679-2011-00028
- Event Type
- Malfunction
- Date Received
- July 26, 2011
- Date of Event
- May 26, 2011
- Report Date
- June 29, 2011
- Manufacturer
- STRYKER NAVIGATION
- Product Code
- HAW
- PMA / PMN Number
- K993239
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS EVALUATED AT THE FACILITY BY A MANUFACTURER REPRESENTATIVE. THE SYSTEM PASSED ALL SPECIFICATIONS. THE SYSTEM HAS BEEN USED SINCE THE REPORTED EVENT WITH NO ISSUES.
Description of Event or Problem · 1
IT WAS REPORTED THAT TOWARD THE END OF AN IMAGE GUIDED SINUS SURGERY, THE NAVIGATION SYSTEM GAVE AN ERROR AND SHUT DOWN. THE SYSTEM WAS ABLE TO BE RESTARTED, BUT THE SURGEON MADE THE DECISION TO ABORT THE REMAINDER OF THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NAVIGATION SYSTEM II - CART | HAW | STRYKER NAVIGATION | 100273 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |