FDA Adverse Event
Malfunction
Summary report: N
AMBIENT SUPER TURBOVAC 90 WITH INTEGRATED FING
MDR report key: 2872451
·
Received December 11, 2012
Report
- Report Number
- 3006524618-2012-00957
- Event Type
- Malfunction
- Date Received
- December 11, 2012
- Date of Event
- October 23, 2012
- Report Date
- November 13, 2012
- Manufacturer
- ARTHROCARE CORPORATION
- Product Code
- GEI
- PMA / PMN Number
- K083306
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE UNITED STATES. AS A RESULT OF FOREIGN CONFIDENTIALITY REQUIREMENTS AND INTERNATIONAL PRIVACY LAWS, NO PT INFO WAS AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN ARTHROSCOPIC PROCEDURE USING THE AMBIENT SUPER TURBOVAC 90 IFS, THE WAND WOULD NOT FUNCTION IMMEDIATELY AFTER OPENING. THE PROCEDURE WAS UNABLE TO BE COMPLETED WITH ARTHROCARE PRODUCTS, HOWEVER, NO FURTHER INFO REGARDING THE PROCEDURE OUTCOME WAS PROVIDED. THERE WERE NO REPORTED PT COMPLICATIONS
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AMBIENT SUPER TURBOVAC 90 WITH INTEGRATED FING | ELECTRODE, ELECTROSURGICAL, ACTIVE, HAND | GEI | ARTHROCARE CORPORATION | 0116320-C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |