FDA Adverse Event
Other
Summary report: N
TOPAZ MICRODEBRIDER W/ INTEGRATED FINGER SWITC
MDR report key: 2222541
·
Received August 11, 2011
Report
- Report Number
- 2951580-2011-00110
- Event Type
- Other
- Date Received
- August 11, 2011
- Date of Event
- July 1, 2011
- Report Date
- August 11, 2011
- Manufacturer
- ARTHROCARE CORP.
- Product Code
- GEI
- PMA / PMN Number
- K080282
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS REPORTED AS DISCARDED FOLLOWING THE PROCEDURE. A REVIEW OF THE LOT HISTORY RECORD WILL BE PERFORMED AND PROVIDED IN A F/U REPORT.
Description of Event or Problem · 1
DURING AN ARTHROSCOPIC PROCEDURE USING A TOPAZ ARTHROWAND, THE WAND REPORTEDLY BEGAN SPARKING. THE WAND STOPPED WORKING IMMEDIATELY AFTER THE SPARKING CEASED. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOPAZ MICRODEBRIDER W/ INTEGRATED FINGER SWITC | ELECTROSURGICAL CUTTING & COAGULATION DE | GEI | ARTHROCARE CORP. | AT12910-A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |