BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA DUODENOVIDEOSCOPE

    MDR report key: 24570806 · Received March 11, 2026

    Report

    Report Number
    9610595-2026-20560
    Event Type
    Malfunction
    Date Received
    March 11, 2026
    Date of Event
    January 21, 2026
    Report Date
    March 11, 2026
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE WAS CONFIRMED. IN ADDITION, THE FOLLOWING REPORTABLE MALFUNCTIONS WERE IDENTIFIED DURING THE DEVICE EVALUATION: ADHESIVE AT THE LIGHT GUIDE LENS COMING OFF. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: KNOWN INHERENT RISK OF DEVICE. 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 ADHESIVE AT THE LIGHT GUIDE LENS COMING OFF. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632697 EVIS LUCERA DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT AIZU OLYMPUS CO., LTD. JF-260V

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown