BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVASURE

    MDR report key: 3082099 · Received April 25, 2013

    Report

    Report Number
    3082099
    Event Type
    Malfunction
    Date Received
    April 25, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 25, 2013
    Manufacturer
    HOLOGIC, INC
    Product Code
    MNB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US

    Narratives

    Description of Event or Problem · 1

    NOVASURE DEVICE WAS INSERTED INTO THE UTERUS BUT FAILED TO OPERATE.THE DEVICE DID NOT WORK FROM THE FIRST ATTEMPT. THERE WAS NO PATIENT HARM. THERE WAS AN UNRELATED ISSUE WHICH CAUSED THE NOVASURE USE TO BE CANCELED. THE STAFF/SURGEON DOES NOT KNOW WHAT MAY HAVE CAUSED OR CONTRIBUTED TO THE DEVICE NOT WORKING. THE REP KNOWS ABOUT THE FAILURE AND THE DEVICE IS STILL AT THE HOSPITAL.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?DIAGNOSTIC HYSTERECTOMY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180166 NOVASURE DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB HOLOGIC, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR