FDA Adverse Event
Other
Summary report: N
SUPER TURBOVAC WITH INTEGRATED CABLE
MDR report key: 1061133
·
Received June 18, 2008
Report
- Report Number
- 2951580-2008-00039
- Event Type
- Other
- Date Received
- June 18, 2008
- Date of Event
- January 9, 2008
- Report Date
- June 16, 2008
- Manufacturer
- ARTHROCARE CORP.
- Product Code
- GEI
- PMA / PMN Number
- K072865
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS REPORTED TO BE AVAILABLE FOR INVESTIGATION. AWAITING RETURN OF DEVICE TO COMPLETE THE INVESTIGATION FOR THIS REPORT.
Description of Event or Problem · 1
IN 2008, A CLINICAL INCIDENT INVOLVING A SUPER TURBOVAC WAS REPORTED TO ARTHROCARE CORPORATION. FOLLOWING A HIP ARTHROSCOPY PROCEDURE, IT WAS REPORTED THE ELECTRODE HAD DETACHED FROM THE TIP OF THE WAND AND REMAINS IN THE PATIENT'S HIP. THERE WAS NO REPORTED PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SUPER TURBOVAC WITH INTEGRATED CABLE | ELECTROSURGICAL CUTTING & COAGULATION DEVICE | GEI | ARTHROCARE CORP. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |