BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EYE MAX SCOPE

    MDR report key: 22545778 · Received July 18, 2025

    Report

    Report Number
    MW5172949
    Event Type
    Malfunction
    Date Received
    July 18, 2025
    Date of Event
    July 10, 2025
    Report Date
    July 15, 2025
    Manufacturer
    MICRO-TECH USA, INC.
    Product Code
    KQM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    WHILE DOING AN ERCP(ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY), THE EYES MAX EQUIPMENT MALFUNCTIONED TWICE, THE INTEGRATED LAMP STOPPED WORKING, WE WERE UNABLE TO USE THIS EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2784673 EYE MAX SCOPE CAMERA, SURGICAL AND ACCESSORIES KQM MICRO-TECH USA, INC. CDS22007 M250514709

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Other