FDA Adverse Event
Injury
Summary report: N
SUPER TURBOVAC 90 WITH INTEGRATED CABLE
MDR report key: 1845887
·
Received September 17, 2010
Report
- Report Number
- 2951580-2010-00086
- Event Type
- Injury
- Date Received
- September 17, 2010
- Date of Event
- May 18, 2010
- Report Date
- September 17, 2010
- Manufacturer
- ARTHROCARE CORP.
- Product Code
- GEI
- PMA / PMN Number
- K083306
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS REPORTED AS RETURNING FOR INVESTIGATION. AWAITING AVAILABILITY OF DEVICE TO COMPLETE THE INVESTIGATION. THE SECOND DEVICE, QUANTUM 2 CONTROLLER, USED IN THE SAME PROCEDURE IS REPORTED UNDER MEDWATCH NUMBER 2951580-2010-00087.
Description of Event or Problem · 1
DURING A SHOULDER ARTHROSCOPY PROCEDURE USING A SUPER TURBOVAC 90 WITH INTEGRATED CABLE ARTHROWAND AND QUANTUM 2 CONTROLLER, THE PT SUSTAINED A SECOND DEGREE BURN APPROX 4 CM IN SIZE. THE BURN WAS TREATED WITH SILVEDERMA CREAM. THE PHYSICIAN REPORTED THE CAUSE OF THE BURN WAS DUE TO HIGH TEMPERATURE WATER FLOW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SUPER TURBOVAC 90 WITH INTEGRATED CABLE | ELECTROSURGICAL CUTTING & COAGULATION DE | GEI | ARTHROCARE CORP. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Other |