BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIZISHOT EBUS

    MDR report key: 4091302 · Received September 2, 2014

    Report

    Report Number
    4091302
    Event Type
    Malfunction
    Date Received
    September 2, 2014
    Date of Event
    July 11, 2014
    Report Date
    August 27, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP
    Product Code
    FCG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US

    Narratives

    Description of Event or Problem · 1

    RN WAS SETTING UP THE RADIAL EBUS (ENDOBRONCHIAL ULTRASOUND TRANSBRONCHIAL ASPIRATION) SCOPE AND WAS UNABLE TO GET WATER IN THE BALLOON. RN TRIED 2 OTHER BALLOONS, THEN CHANGED OUT THE AIR WATER BUTTON, AND THE SCOPE WORKED FINE. TWO AIR WATER BUTTONS WERE SAVED FOR INVESTIGATION. NO PATIENT WAS HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533040 VIZISHOT EBUS SINGLE USE ASPIRATION NEEDLE FCG OLYMPUS MEDICAL SYSTEMS CORP * *
    533041 VIZISHOT EBUS SINGLE USE ASPIRATION NEEDLE FCG OLYMPUS MEDICAL SYSTEMS CORP * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES