BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBLATOR II

    MDR report key: 3871672 · Received April 16, 2014

    Report

    Report Number
    3006524618-2014-00107
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Date of Event
    March 12, 2014
    Report Date
    March 17, 2014
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K030108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A TONSILLECTOMY PROCEDURE USING A COBLATOR II CONTROLLER, THE UNIT FAILED TO POWER ON. THE SURGEON OPTED TO COMPLETE THE PROCEDURE USING A COMPETITIVE DEVICE. 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
    233775 COBLATOR II OPERATOR CONSOLE, DIATHERMY UNIT GEI ARTHROCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Other