BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLOGIC - NOVASURE

    MDR report key: 2468917 · Received February 21, 2012

    Report

    Report Number
    MW5024386
    Event Type
    Malfunction
    Date Received
    February 21, 2012
    Date of Event
    January 31, 2012
    Report Date
    February 21, 2012
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS SCHEDULED FOR A DILATATION AND CURETTAGE AND ENDOMETRIAL ABLATION. THE NOVASURE DEVICE WAS LOADED AND ENABLED. THE ENDOMETRIAL DEVICE FAILED DURING THE TESTING OF THE UTERINE CAVITY. THE DEVICE WAS UNABLE TO PERFORM THE CO2 ASSESSMENT. THE ENDOMETRIAL ABLATION WAS UNABLE TO BE PERFORMED. ONE OF 2 DEVICES, BOTH FAILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOLOGIC - NOVASURE ENDOMETRIAL ABLATION DEVICE KIT MNB HOLOGIC NS 2000 11J05RA
    2 HOLOGIC - NOVASURE ENDOMETRIAL ABLATION DEVICE KIT MNB HOLOGIC NS 2000 11G29RA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR