BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUTTONSWITCH PENCIL

    MDR report key: 1904222 · Received November 15, 2010

    Report

    Report Number
    1717344-2010-00819
    Event Type
    Malfunction
    Date Received
    November 15, 2010
    Date of Event
    October 15, 2010
    Report Date
    October 19, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CORD WAS SLICED AND A BARE WIRE WAS VISIBLE. THE PENCIL FAILED HIPOT TESTING CONFIRMING A BREAK IN THE INSULATION. WHEN PLUGGED INTO A GENERATOR, THE DEVICE WOULD NOT ACTIVATE. THE CORD APPEARS TO HAVE BEEN CAUGHT ON SOMETHING THAT SLICED THE CORD. EVERY CORD IS 100% VISUALLY INSPECTED DURING MFG AND EVERY PENCIL IS 100% TESTED FOR FUNCTIONALITY. IN ADDITION, A SAMPLING FROM EVERY LOT IS HIPOT TESTED. THE IFU WARNS, INSPECT ACCESSORIES AND CORDS FOR BREAKS, CRACKS, AND OTHER DAMAGE BEFORE EVERY USE. IF DAMAGED, DO NOT USE. FAILURE TO OBSERVE THIS CAUTION MAY RESULT IN INJURY OR ELECTRICAL SHOCK TO THE PT OR SURGICAL TEAM.

    Description of Event or Problem · 1

    THE CUSTOMER INITIALLY REPORTED THAT WHILE IN USE, THE CORD CAUSED AN ALTERNATE SITE BURN. INSULATION LOOKS TO BE DAMAGED. THE BURN WAS SUPERFICIAL ABOUT 1/4 INCH DIAMETER. IT WAS ONLY NOTICED POST-SURGERY. UPON RETURN AND EVAL OF THE DEVICE, IT WAS FOUND TO FAIL HIPOT TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BUTTONSWITCH PENCIL ELECTROSURGICAL ACCESSORY GEI COVIDIEN LP (VALLEYLAB) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK