BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBLATOR II

    MDR report key: 3240986 · Received July 17, 2013

    Report

    Report Number
    3006524618-2013-00292
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 15, 2013
    Report Date
    June 18, 2013
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    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 DURING AN ADENOIDECTOMY PROCEDURE USING A COBLATOR II CONTROLLER WITH A PROCISE MAX WAND, THE CONTROLLER BEGAN SPARKING AND SMOKING FROM THE WAND PORT, AFTER CONNECTING THE WAND. THE PROCEDURE WAS POSTPONED, AS THE FACILITY DID NOT HAVE A BACK UP DEVICE. THE DETAILS REGARDING THE RESCHEDULED PROCEDURE WERE NOT PROVIDED; HOWEVER, NO PT COMPLICATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332059 COBLATOR II OPERATOR CONSOLE, DIATHERMY UNIT GEI ARTHROCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Other EIC8898-01 PROCISE MAX WAND