BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCE FX

    MDR report key: 1912935 · Received November 18, 2010

    Report

    Report Number
    1717344-2010-00909
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    November 11, 2010
    Report Date
    November 11, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURN OF THE INCIDENT SAMPLE HAS BEEN REQUESTED. TO DATE, IT HAS NOT BEEN RECEIVED FOR EVAL. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFO PERTINENT TO THE INCIDENT IS OBTAINED, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SURGEON ACTIVATED THE MONOPOLAR PENCIL AND THE BIPOLAR FORCEP ACTIVATED ON ITS OWN AT THE SAME TIME. THE PT SUSTAINED A SUPERFICIAL BURN, 1MM IN LENGTH ON THE NECK. THE HOSP BIOMEDICAL ENGINEER TESTED THE UNIT IN THE OPERATING ROOM AND FOUND ENERGY COMING OUT OF THE BIPOLAR WHEN THE MONOPOLAR WAS ACTIVATED. WHEN THE UNIT WAS TESTED IN THE BIOMEDICAL ENGINEERING DEPT, NO PROBLEMS WERE DETECTED. THE GENERATOR IS STILL AT THE CUSTOMER'S AND THE HOSPITAL HAS NOT YET CONSENTED FOR EVAL BY COVIDIEN. THE PT HAS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORCE FX ELECTROSURGICAL GENERATOR GEI COVIDIEN LP (VALLEYLAB)

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK