BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III DUODENOVIDEOSCOPE

    MDR report key: 24169038 · Received January 23, 2026

    Report

    Report Number
    9610595-2026-08305
    Event Type
    Malfunction
    Date Received
    January 23, 2026
    Date of Event
    July 25, 2025
    Report Date
    January 23, 2026
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDT
    PMA / PMN Number
    K251867
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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, THE MOST PROBABLE CAUSE OF THE COMPLAINT IS ATTRIBUTED TO A COMPONENT FAILURE. FOR THE Z-BLOCK(SERVER PLUG-IN), AW-TUBE, AND AW-CYLINDER, WHICH WERE FOUND TO CONTAIN FOREIGN OBJECTS, THE MOST PROBABLE CAUSE OF THE COMPLAINT 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 ADHESIVE AROUND OBJECTIVE LENS HAS A CHIP, FOREIGN OBJECTS AT Z-BLOCK(SERVER PLUG-IN) , AIR WATER -TUBE AND AIR WATER-CYLINDER. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233018 EVIS EXERA III DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT AIZU OLYMPUS CO., LTD. TJF-Q190V

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown