FDA Adverse Event
Malfunction
Summary report: N
REPAIR ENLITE
MDR report key: 2033951
·
Received March 23, 2011
Report
- Report Number
- 3007582679-2011-00012
- Event Type
- Malfunction
- Date Received
- March 23, 2011
- Date of Event
- February 23, 2011
- Report Date
- February 23, 2011
- Manufacturer
- STRYKER NAVIGATION
- Product Code
- HAW
- PMA / PMN Number
- K993239
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER, BUT THE LOG FILES FROM THE CASE WILL BE AVAILABLE FOR EVALUATION. THE INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A FESS PROCEDURE, THE NURSE COULD NOT PROGRESS PAST THE REGISTRATION OF THE PT. AFTER ONE HOUR OF TROUBLESHOOTING, IT WAS DECIDED TO CONTINUE ON WITH THE PROCEDURE WITHOUT THE USE OF NAVIGATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ALLEGATION OF ADVERSE CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REPAIR ENLITE | STEREOTAXIC INSTRUMENT | HAW | STRYKER NAVIGATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |