BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOW CONTROL VALVE UNIT

    MDR report key: 3140023 · Received May 29, 2013

    Report

    Report Number
    3006524618-2013-00206
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 30, 2013
    Report Date
    April 30, 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 PROCEDURE USING THE COBLATOR 2 SYSTEM, THE FLOW CONTROL VALVE WAS NOT FUNCTIONING PROPERLY. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE, HOWEVER, DUE TO THIS ISSUE, THE PROCEDURE TOOK AN ADDITIONAL 2 HOURS MORE THAN EXPECTED. THERE WERE NO PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233624 FLOW CONTROL VALVE UNIT ELECTROSURGICAL CUTTING AND COAGULATION DE GEI ARTHROCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other