FDA Adverse Event
Malfunction
Summary report: N
AMBIENT SUPER TURBOVAC 90 WITH FINGER SWITCH
MDR report key: 2331827
·
Received October 21, 2011
Report
- Report Number
- 2951580-2011-00202
- Event Type
- Malfunction
- Date Received
- October 21, 2011
- Date of Event
- September 1, 2011
- Report Date
- September 29, 2011
- Manufacturer
- ARTHROCARE CORP.
- Product Code
- GEI
- PMA / PMN Number
- K083306
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE PT'S AGE AND GENDER HAVE BEEN REQUESTED BUT THE INITIAL REPORTER REFUSED TO RELEASE SUCH INFO. REFERENCE MFR'S REPORT # 2951580-2011-00203, 2951580-2011-00204.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN ARTHROSCOPIC KNEE MENISECTOMY USING THE AMBIENT SUPER TURBOVAC 90 ARTHOWAND AND A QUANTUM II CONTROLLER, THE FIRST WAND DISPLAYED AN UNK ERROR MESSAGE. A SECOND SUPER TURBOVAC 90 ARTHOWAND WAS PLUGGED IN AND AGAIN AN UNK ERROR MESSAGE WAS DISPLAYED. THERE WAS A SIGNIFICANT DELAY IN THE PROCEDURE, REPORTEDLY 35-40 MINS. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE DEVICE. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AMBIENT SUPER TURBOVAC 90 WITH FINGER SWITCH | ELECTROSURGICAL CUTTING & COAGULATION DE | GEI | ARTHROCARE CORP. | 0121110-A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |