BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II DUODENOVIDEOSCOPE

    MDR report key: 23181364 · Received September 30, 2025

    Report

    Report Number
    9610595-2025-23232
    Event Type
    Malfunction
    Date Received
    September 30, 2025
    Date of Event
    September 10, 2025
    Report Date
    September 30, 2025
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDT
    PMA / PMN Number
    K143153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. BASED ON THE RESULTS OF THE INVESTIGATION, THE DEVICE WAS EVALUATED, AND REPORTABLE MALFUNCTIONS WERE NOTED WHERE THE LIGHT GUIDE COVER GLASS ADHESIVE AND CHARGED COUPLED DEVICE COVER LENS ADHESIVE WERE CHIPPED. HOWEVER, A DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. 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 DURING THE DEVICE EVALUATION, THE LIGHT GUIDE COVER GLASS ADHESIVE AND CHARGED COUPLED DEVICE COVER LENS ADHESIVE OF THE DUODENOVIDEOSCOPE WERE CHIPPED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1658918 EVIS EXERA II DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT AIZU OLYMPUS CO., LTD. TJF-Q180V

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown