BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVASURE

    MDR report key: 3232372 · Received July 8, 2013

    Report

    Report Number
    3232372
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    February 7, 2013
    Report Date
    July 8, 2013
    Manufacturer
    HOLOGIC, INC.
    Product Code
    MNB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US

    Narratives

    Description of Event or Problem · 1

    PATIENT FOR HYSTEROSCOPY AND NOVASURE ABLATION. THE NOVASURE WAS INSERTED INTO THE UTERUS - CAVITY MEASUREMENTS ENTERED INTO MACHINE HANDPIECE WOULD NOT PASS CAVITY ASSESSMENT TEST. THE NOVASURE WOULD NOT SEAL TO PROCEED WITH ABLATION. UNABLE TO DO ABLATION PART OF PROCEDURE. THE REPRESENTATIVE FOR THE PRODUCT WAS PRESENT. THE PRODUCT WAS FROM THE SAME LOT BATCH THAT MALFUNCTIONED LAST WEEK. THE REP FEELS THAT IT IS A BAD LOT NUMBER (BATCH).WHAT WAS THE ORIGINAL INTENDED PROCEDURE?LAPAROSCOPIC BILATERAL TUBAL LIGATION; HYSTERSCOPY D & C AND NOVASURE ENDOMETRIAL ABLATION.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310973 NOVASURE DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB HOLOGIC, INC. * 12H10R

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR