BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBLATOR II

    MDR report key: 3813307 · Received March 28, 2014

    Report

    Report Number
    3006524618-2014-00084
    Event Type
    Malfunction
    Date Received
    March 28, 2014
    Date of Event
    February 22, 2014
    Report Date
    February 28, 2014
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K030108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SETUP FOR A PROCEDURE USING A COBLATOR II CONTROLLER, THE UNIT WAS DISPLAYING A FUSE ERROR. THE FUSE WAS REPLACED, HOWEVER THE ERROR REMAINED. THE PROCEDURE WAS POSTPONED UNTIL THE FOLLOWING DAY, AT WHICH TIME THE SURGEON OPTED TO CONDUCT THE PROCEDURE USING A COMPETITIVE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184828 COBLATOR II OPERATOR CONSOLE, DIATHERMY UNIT GEI ARTHROCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1