BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVAC 70 XTRA PLASMA WAND

    MDR report key: 2852676 · Received November 14, 2012

    Report

    Report Number
    3006524618-2012-00879
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 12, 2012
    Report Date
    October 16, 2012
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K033257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT IDENTIFIER, AGE AND WEIGHT WERE NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TONSILLECTOMY/ADENOIDECTOMY PROCEDURE, THE EVAC 70 XTRA PLASMA WAND CLOGGED IMMEDIATELY. A NEW EVAC 70 XTRA PLASMA WAND WAS OPENED AND THIS CLOGGED IMMEDIATELY AS WELL. THE SURGERY WAS COMPLETED USING A COMPETITOR'S PRODUCT. THERE WERE NO DELAYS OR PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVAC 70 XTRA PLASMA WAND ELECTROSURGICAL CUTTING & COAGULATION DE GEI ARTHROCARE CORPORATION B232210-A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other