BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESSURE

    MDR report key: 3231135 · Received July 11, 2013

    Report

    Report Number
    3231135
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    July 9, 2013
    Report Date
    July 10, 2013
    Manufacturer
    CONCEPTUS, INC.
    Product Code
    HHS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHEN THE PHYSICIAN WAS READY TO ENGAGE THE ESSURE HANDPIECE, IT MISFIRED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?ESSURE-PERMANENT STERILIZATION.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321300 ESSURE DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE HHS CONCEPTUS, INC. NA A25168

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR THE HYSTEROSCOPE WAS BEING USED TO ACCESS| VISUALIZATION OF THE UTERUS