BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVASURE

    MDR report key: 1867921 · Received October 4, 2010

    Report

    Report Number
    1867921
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    August 27, 2010
    Report Date
    October 4, 2010
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TWO SEPARATE NOVASURE HANDPIECES DID NOT FUNCTION CORRECTLY DURING CASE DESPITE TROUBLESHOOTING EFFORTS OF THE STAFF, PHYSICIAN, AND NOVASURE TECHNICAL SUPPORT VIA PHONE (1-800-442-9892.) PERFORATION OF UTERUS SUSPECTED BY PHYSICIAN UPON HYSTEROSCOPY FOLLOWING ABLATION ATTEMPTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVASURE NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM MNB HOLOGIC * 10D28RA
    2 NOVASURE NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABALATION SYSTEM MNB HOLOGIC * 10C04RA

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR