BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVASURE

    MDR report key: 1101603 · Received July 30, 2008

    Report

    Report Number
    1101603
    Event Type
    Malfunction
    Date Received
    July 30, 2008
    Date of Event
    July 29, 2008
    Report Date
    July 30, 2008
    Manufacturer
    CYTYC SURGICAL
    Product Code
    MNB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US

    Narratives

    Description of Event or Problem · 1

    PRIOR TO PATIENT IN ROOM, TECHNICIAN TURNED ON MACHINE TO TEST. MACHINE WOULD NOT TURN ON THE FIRST TIME. CHECKED CORDS AND TURNED OFF/ON. FINALLY MACHINE STARTED AFTER THIRD ATTEMPT. MACHINE WAS THEN TURNED OFF UNTIL PROCEDURE STARTED. WHEN DR. ATTEMPTED TO DO CAVITY ASSESSMENT AND NURSE PUSHED ARROW TO START MACHINE, IT WENT RIGHT TO ENABLE (ALL LIGHTS CAME ON). WE THEN SHUT DOWN THE MACHINE AND CHECKED ALL CORDS. THE MACHINE WAS TURNED BACK ON, AND ALL CORDS WERE REPLUGGED. THE SETTINGS WERE RE-ENTERED, AND THEN PUSHED THE CAVITY ASSESSMENT. THIS TIME THE LIGHT CAME ON BRIEFLY, THEN ERROR/ARRAY LIGHT CAME ON. WE SHUT OFF THE MACHINE, UNPLUGGED EVERYTHING, AND TURNED IT BACK ON. EVERYTHING WAS PLUGGED BACK IN. ALL LIGHTS STARTED FLASHING, THEN THE MACHINE STARTED BEEPING. DOCTOR ABORTED THE CASE AT THAT TIME. NO INJURY TO THE PATIENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVASURE CONTROLLER, ABLATION, ENDOMETRIAL MNB CYTYC SURGICAL 7277 07L07HB07111

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR