FDA Adverse Event
Injury
Summary report: N
SUPER TURBOVAC WITH INTEGRATED CABLE
MDR report key: 1153239
·
Received September 10, 2008
Report
- Report Number
- 2951580-2008-00067
- Event Type
- Injury
- Date Received
- September 10, 2008
- Date of Event
- August 4, 2008
- Report Date
- September 8, 2008
- Manufacturer
- ARTHROCARE CORP.
- Product Code
- GEI
- PMA / PMN Number
- K072865
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED TO THE MFR, THEREFORE, A COMPLETE INVESTIGATION CANNOT BE PERFORMED. AWAITING FURTHER INFORMATION REGARDING USAGE OF DEVICE DURING SURGICAL PROCEDURE AS PART OF INVESTIGATION.
Description of Event or Problem · 1
IN 2008, A CLINICAL INCIDENT INVOLVING A SUPER TURBOVAC WITH INTEGRATED CABLE ARTHROWAND WAS REPORTED TO ARTHROCARE CORPORATION. ONE DAY FOLLOWING A SHOULDER ARTHROSCOPY PROCEDURE, IT WAS REPORTED THE PATIENT SUSTAINED A BURN (SEVERITY NOT KNOWN) ON PATIENT'S ARM AND ELBOW. AWAITING FURTHER INFORMATION REGARDING PATIENT STATUS AND TREATMENT.
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 |