FDA Adverse Event
Injury
Summary report: N
ULTRAVAC WITH INTEGRATED CABLE
MDR report key: 1238283
·
Received November 21, 2008
Report
- Report Number
- 2951580-2008-00080
- Event Type
- Injury
- Date Received
- November 21, 2008
- Date of Event
- October 22, 2008
- Report Date
- November 18, 2008
- Manufacturer
- ARTHROCARE CORP.
- Product Code
- GEI
- PMA / PMN Number
- K072865
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION. INVESTIGATION OF THE REPORT IS IN PROGRESS.
Description of Event or Problem · 1
IN 2008, A CLINICAL INCIDENT INVOLVING A ULTRAVAC WITH INTEGRATED CABLE ARTHROWAND WAS REPORTED TO ARTHROCARE CORPORATION. DURING A KNEE ARTHROSCOPY PROCEDURE, IT WAS REPORTED THE PATIENT SUSTAINED AN INTERJOINT BURN (SEVERITY NOT KNOWN) BENEATH THE SKIN IN THE MEDICAL GUTTER REGION OF PATIENT'S KNEE. THE BURN WAS APPROXIMATELY 1.5 INCHES WIDE AND 3 MM WIDE. IT WAS REPORTED ONE WEEK FOLLOWING THE PROCEDURE THE PATIENT'S BURN HAD HEALED. NO ADDITIONAL PROCEDURES WERE REQUIRED TO TREAT THE BURN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ULTRAVAC WITH INTEGRATED CABLE | ELECTROSURGICAL CUTTING & COAGULATION DEVICE | GEI | ARTHROCARE CORP. | NA | SE22670-B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |