BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEO FLEXIBLE HYSTEROSCOPE

    MDR report key: 4850318 · Received June 11, 2015

    Report

    Report Number
    MW5043103
    Event Type
    Malfunction
    Date Received
    June 11, 2015
    Date of Event
    June 11, 2015
    Report Date
    June 11, 2015
    Manufacturer
    OLYMPUS
    Product Code
    HIH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    USING OLYMPUS HYSTEROSCOPE HYF-V. AT TIME OF PROCEDURE A BLACK APPROX. 2MM SEMI-CIRCULAR FOREIGN BODY WAS NOTED INSIDE OF UTERUS. IT WAS REMOVED AND NOTED TO BE TIP OF THE SCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380849 VIDEO FLEXIBLE HYSTEROSCOPE HIH OLYMPUS HYF-V

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR