BEUDAMED
    FDA Adverse Event Other Summary report: N

    TURBOVAC 90 ARTHROWAND

    MDR report key: 966087 · Received December 18, 2007

    Report

    Report Number
    2951580-2007-00078
    Event Type
    Other
    Date Received
    December 18, 2007
    Date of Event
    November 13, 2007
    Report Date
    December 13, 2007
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    PMA / PMN Number
    K070958
    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. A REVIEW OF THE LOT HISTORY RECORD WAS PERFORMED. THE DEVICE MET ALL SPECIFICATIONS. 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 2951580-2007-00078 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 TURBOVAC 90 ARTHROWAND ELECTROSURGICAL DEVICE & ACCESSORIES GEI ARTHROCARE CORP. NA 4G07270-A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR