FDA Adverse Event
Malfunction
Summary report: N
STEALTHSTATION IOR SYSTEM
MDR report key: 2438150
·
Received January 12, 2012
Report
- Report Number
- 1723170-2012-00023
- Event Type
- Malfunction
- Date Received
- January 12, 2012
- Date of Event
- December 27, 2011
- Report Date
- December 27, 2011
- Manufacturer
- MEDTRONIC NAVIGATION, INC.
- Product Code
- HAW
- PMA / PMN Number
- K050438
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
RMAS HAVE BEEN ASSIGNED BUT NOT ALL COMPONENTS HAVE BEEN RECEIVED BY THE MFR FOR EVAL.
Description of Event or Problem · 1
A MEDTRONIC REP REPORTED THAT THE INTEGRATED OPERATING ROOM SYSTEM'S CAMERA LOST COMMUNICATION AS THEY WERE PREPARING TO TRACK THE BIOPSY NEEDLE (HAD NOT YET BEEN PASSED INTO THE HEAD). THEY WERE UNABLE TO GET COMMUNICATION BACK BUT THEY ARCHIVED THE EXAM ONTO A CD AND TRANSFERRED IT TO AN INAV, AND THE CASE WAS CONTINUED. NO PT HARM WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STEALTHSTATION IOR SYSTEM | STEREOTAXIC INSTRUMENT (HAW) | HAW | MEDTRONIC NAVIGATION, INC. | IOR | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR |