BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVASURE

    MDR report key: 2060090 · Received April 6, 2011

    Report

    Report Number
    2060090
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    February 2, 2011
    Report Date
    April 6, 2011
    Manufacturer
    HOLOGIC, INC.
    Product Code
    MNB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    SETTINGS WERE SET ON MACHINE PER SURGEON. ARRAY POSITION, RED FLASHING LIGHT AND CAVITY ASSESSMENT YELLOW LIGHT FLASHING. ENABLE PUSHED, FOOTSWITCH DEPRESSED AND NOTHING HAPPENED. MACHINE TURNED OFF & STEPS REPEATED PER SURGEON. STILL NOTHING HAPPENED. NOVASURE REP CALLED AND PUT ON SPEAKER PHONE TO TALK WITH SURGEON AND STAFF. MACHINE TURNED BACK ON AND SETTINGS WERE SET BY REP PER SURGEON. DEVICE STILL DID NOT WORK. REPEATED ALL STEPS ONE MORE TIME, AND MACHINE STILL DID NOT WORK. DEVICE REMOVED FROM FIELD & GIVEN TO (B) 6) TO RETURN OR CONTACT MANUFACTURER A NEW DEVICE OPENED ON FIELD AND SETTINGS RESET BY NOVASURE REP PER SURGEON. NEW DEVICE WORKED AND PROCEDURE COMPLETED.

    Description of Event or Problem · 1

    SETTINGS WERE SET ON MACHINE PER SURGEON. ARRAY POSITION, RED FLASHING LIGHT AND CAVITY ASSESSMENT YELLOW LIGHT FLASHING. ENABLE PUSHED, FOOTSWITCH DEPRESSED AND NOTHING HAPPENED. MACHINE TURNED OFF & STEPS REPEATED PER SURGEON. STILL NOTHING HAPPENED. NOVASURE REP CALLED AND PUT ON SPEAKER PHONE TO TALK WITH SURGEON AND STAFF. MACHINE TURNED BACK ON AND SETTINGS WERE SET BY REP PER SURGEON. DEVICE STILL DID NOT WORK. REPEATED ALL STEPS ONE MORE TIME, AND MACHINE STILL DID NOT WORK. DEVICE REMOVED FROM FIELD & GIVEN TO SPD TO RETURN OR CONTACT MANUFACTURER A NEW DEVICE OPENED ON FIELD AND SETTINGS RESET BY NOVASURE REP PER SURGEON. NEW DEVICE WORKED AND PROCEDURE COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVASURE ABLATION, ENDOMETRIAL MNB HOLOGIC, INC. NOVASURE 10H17RA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR