BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBLATOR II

    MDR report key: 3101354 · Received May 3, 2013

    Report

    Report Number
    3006524618-2013-00170
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 26, 2013
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K030108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TONSILLECTOMY PROCEDURE USING THE COBLATOR II CONTROLLER WITH AN UNKNOWN ARTHROWAND, THE COAGULATION FUNCTION SEEMED TO CAUSE THE PATIENT TO BLEED MORE, RATHER THAN STOP THE BLEEDING. THE SURGEON WAS ABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE BY DECREASING THE COAGULATION POWER SETTING ON THE DEVICE. THERE WAS NO SIGNIFICANT DELAYS OR PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194380 COBLATOR II OPERATOR CONSOLE, DIATHERMY UNIT GEI ARTHROCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other UNKNOWN ARTHROWAND