BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBLATOR II (120V)

    MDR report key: 2945110 · Received January 31, 2013

    Report

    Report Number
    3006524618-2013-00046
    Event Type
    Malfunction
    Date Received
    January 31, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 4, 2013
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K030108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TONSILLECTOMY/ADENOIDECTOMY PROCEDURE USING THE EVAC 70 XTRA HP AND COBLATOR 2 SYS, THE CONTROLLER WOULD NOT FORM A PLASMA FIELD. THE PROCEDURE WAS ULTIMATELY COMPLETED WITH A COMPETITOR'S BOVIE PRODUCT. THERE WERE NO SIGNIFICANT DELAYS OR PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42617 COBLATOR II (120V) OPERATOR CONSOLE, DIATHERMY UNIT GEI ARTHROCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Other