BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III DUODENOVIDEOSCOPE

    MDR report key: 24344224 · Received February 16, 2026

    Report

    Report Number
    9610595-2026-14957
    Event Type
    Malfunction
    Date Received
    February 16, 2026
    Date of Event
    October 13, 2025
    Report Date
    February 16, 2026
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDT
    PMA / PMN Number
    K251867
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: THE CAUSE OF THE DISCOLORATION OF ADHESIVE AROUND THE LIGHT GUIDE (LG) LENS IS TRACED TO COMPONENT FAILURE, HOWEVER THE CAUSE OF THE FOREIGN OBJECTS AT Z-BLOCK (SERVER PLUG-IN) COULD NOT BE ESTABLISHED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE DUODENOVIDEOSCOPE HAD DISCOLORATION OF ADHESIVE AROUND THE LIGHT GUIDE (LG) LENS AND FOREIGN OBJECTS AT Z-BLOCK (SERVER PLUG-IN). THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407852 EVIS EXERA III DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT AIZU OLYMPUS CO., LTD. TJF-Q190V

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown