BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOENDO

    MDR report key: 24776140 · Received April 3, 2026

    Report

    Report Number
    24776140
    Event Type
    Malfunction
    Date Received
    April 3, 2026
    Date of Event
    March 5, 2026
    Report Date
    March 27, 2026
    Manufacturer
    EVOENDO, INC.
    Product Code
    FDS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    LOSS OF IMAGE RELATED TO ARTIFACT AND FAILURE OF LIGHT ON SCOPE MID PROCEDURE. TEAM ATTEMPTED TO REPLUG IN SCOPE AND POWER ON AND OFF SYSTEM AND IT DID NOT FIX ISSUE. PROGRESSIVELY WORSENED TO THE EXTENT THAT THE PROCEDURE COULD NOT BE CONTINUED AND THE SCOPE NEEDED TO BE WITHDRAWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836843 EVOENDO GASTROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FDS EVOENDO, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Male Other