BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBLATOR FOOT CONTROL UNIT

    MDR report key: 2833871 · Received November 5, 2012

    Report

    Report Number
    3006524618-2012-00866
    Event Type
    Malfunction
    Date Received
    November 5, 2012
    Date of Event
    October 10, 2012
    Report Date
    October 10, 2012
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K033257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT IDENTIFIER, AGE, WEIGHT AND GENDER WERE NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE IT WAS IMMEDIATELY DISCOVERED THAT THE FOOT PEDAL WAS WORKING ONLY INTERMITTENTLY. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATIONS, USING A BOVIE MEDICAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBLATOR FOOT CONTROL UNIT ELECTROSURGICAL CUTTING AND COAGULATION DE GEI ARTHROCARE CORPORATION 141131

    Patients

    Seq Age Sex Outcome Treatment
    1 Other