BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANIPULATOR PRO 37MM

    MDR report key: 6111442 · Received November 17, 2016

    Report

    Report Number
    3008254127-2016-00006
    Event Type
    Malfunction
    Date Received
    November 17, 2016
    Date of Event
    October 19, 2016
    Report Date
    November 16, 2016
    Manufacturer
    SURGI SUPPLIES INTERNATIONAL PTY LTD
    Product Code
    LKF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER THE HYSTERECTOMY, WHEN REMOVING UTERUS FROM PATIENT, THE MANIPULATOR PRO WAS TAKEN OUT WITH PERFORATION IN THE BALLOON. THE "TOP CAP" OF THE BALLOON HAD LOOSENED FROM THE METAL TOP PART OF THE MANIPULATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761974 MANIPULATOR PRO 37MM CANNULA, MANIPULATOR/INJECTOR, UTERINE LKF SURGI SUPPLIES INTERNATIONAL PTY LTD UM-TVPRO-37 ORMP-37-11116

    Patients

    Seq Age Sex Outcome Treatment
    1 Other