BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVASURE

    MDR report key: 2973746 · Received February 20, 2013

    Report

    Report Number
    2973746
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 20, 2013
    Manufacturer
    HOLOGIC, INC.
    Product Code
    MNB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NOVASURE DEVICE IN PLACE AND ARRAYED, AND PROCESS BEGAN. AFTER ONE MINUTE 24 SECONDS THE MACHINE STOPPED AND DISPLAYED "SYSTEM FAULT" ERROR CODE. PROCEDURE ABORTED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?UTERINE D & C WITH ABLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74713 NOVASURE DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB HOLOGIC, INC. * 12E20R

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR NO OTHER THERAPIES