BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EGD SCOPE

    MDR report key: 24942333 · Received April 21, 2026

    Report

    Report Number
    MW5187053
    Event Type
    Malfunction
    Date Received
    April 21, 2026
    Report Date
    April 16, 2026
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHEN THE SCOPE WASHER WAS CLEANING THE SCOPE USED DURING THE EGD, HE NOTICED A LEAK IN THE BIOPSY CHANNEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1009346 EGD SCOPE GASTROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FDS OLYMPUS MEDICAL SYSTEMS CORP. GIF-HQ190

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male