BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ELITE COLONOVIDEOSCOPE

    MDR report key: 24158040 · Received January 22, 2026

    Report

    Report Number
    9610595-2026-07829
    Event Type
    Malfunction
    Date Received
    January 22, 2026
    Date of Event
    December 30, 2025
    Report Date
    February 12, 2026
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D8, G3, G6, H2, H3, H6 CORRECTED H6 MEDICAL DEVICE PROBLEM CODE FROM A0511 STRUCTURAL PROBLEM TO A040605 MATERIAL FRAYED THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE FINAL INVESTIGATION. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE REPORTED FAILURE WAS CONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE IDENTIFIED. THE MOST PROBABLE CAUSE LIKELY LED TO THE FOLLOWING MALFUNCTION: SOME KIND OF STRESS SUCH AS DAMAGE OR DETERIORATION OF PARTS, OPERATIONAL PROBLEM, AND STORAGE PROBLEM. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE COLONOVIDEOSCOPE HAD FRAYED WIRE MESH OUT THE INSERTION SECTION AT THE DISTAL END DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219353 EVIS LUCERA ELITE COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. CF-HQ290I

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown