BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III DUODENOVIDEOSCOPE

    MDR report key: 25033492 · Received April 29, 2026

    Report

    Report Number
    9610595-2026-34965
    Event Type
    Malfunction
    Date Received
    April 29, 2026
    Date of Event
    October 14, 2025
    Report Date
    April 29, 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. IN ADDITION, THE FOLLOWING REPORTABLE MALFUNCTIONS WERE IDENTIFIED DURING THE DEVICE EVALUATION: CHIPPED LIGHT GUIDE COVER LENS ADHESIVE AND CHIPPED CHARGED COUPLED DEVICE COVER ADHESIVE. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: COMPONENT FAILURE. 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 EXHIBITED CHIPPED LIGHT GUIDE COVER LENS ADHESIVE AND CHIPPED CHARGED COUPLED DEVICE COVER ADHESIVE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1098543 EVIS EXERA III DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT AIZU OLYMPUS CO., LTD. TJF-Q190V

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown