FDA Adverse Event
Other
Summary report: N
GE INSTA TRAK 3500
MDR report key: 537301
·
Received July 30, 2004
Report
- Report Number
- 1720753-2004-00002
- Event Type
- Other
- Date Received
- July 30, 2004
- Date of Event
- June 30, 2004
- Report Date
- July 29, 2004
- Manufacturer
- GE HEALTHCARE (OEC MEDICAL SYSTEMS)
- Product Code
- IZL
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DURING AN OUTPATIENT ENDOSCOPIC SINUS SURGICAL PROCEDURE 2004 THE SURGEON WAS NAVIGATING THE PT'S SINUS AND INADVERTENTLY PERFORATED THE ORBITAL AREA AROUND THE EYE. GE SERVICE ENGINEERS WERE SENT TO THE SITE TO INVESTIGATE A POSSIBLE SYSTEM INACCURACY. A DETAILED EXAMINATION OF THE O.R SETTING, THE SYSTEM AND THE LOG FILES REVEALED NO HARDWARE OR SOFTWARE FAILURES THAT COULD ACCOUNT FOR THE ACCURACY PROBLEMS, ALTHOUGH A SYSTEM USE ERROR WAS IDENTIFIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GE INSTA TRAK 3500 | SURGICAL NAVIGATION SYSTEM | IZL | GE HEALTHCARE (OEC MEDICAL SYSTEMS) | INSTA TRAK 3500 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Hospitalization |