FDA Adverse Event
Other
Summary report: N
ARTHROCARE PATIENT CABLE
MDR report key: 966092
·
Received December 18, 2007
Report
- Report Number
- 2951580-2007-00092
- Event Type
- Other
- Date Received
- December 18, 2007
- Date of Event
- November 13, 2007
- Report Date
- December 13, 2007
- Manufacturer
- ARTHROCARE CORP.
- Product Code
- HRX
- PMA / PMN Number
- K943450
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RECEIVED FOR INVESTIGATION. THE INVESTIGATION IS CURRENTLY IN PROGRESS. A FOLLOW UP REPORT IS TO BE PROVIDED FOLLOWING COMPLETION OF INVESTIGATION. TWO DEVICES, TURBOVAC 90 ARTHROWAND (CATALOG NO. AS1335-01) AND ARTHROCARE PT CABLE (CATALOG NO. H0970-02) WERE USED IN THE PROCEDURE AND TWO SEPARATE MDRS ARE FILED FOR EACH DEVICE UNDER MEDWATCH NUMBERS 2951580-207-00078 AND 2951580-2007-00092.
Description of Event or Problem · 1
IN 2007, A CLINICAL INCIDENT INVOLVING A TURBOVAC 90 ARTHROWAND AND AN ARTHROCARE PT CABLE WAS REPORTED TO ARTHROCARE CORP. FOLLOWING AN ARTHROSCOPY PROCEDURE, IT WAS REPORTED THE WAND SHOT FLAMES AT THE CONNECTION BETWEEN THE TURBOVAC 90 ARTHROWAND AND THE ARTHROCARE PT CABLE. NO INJURY WAS CAUSED TO THE PT OR THE PHYSICIAN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ARTHROCARE PATIENT CABLE | ELECTROSURGICAL DEVICE & ACCESSORIES | HRX | ARTHROCARE CORP. | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK YR |