BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 23477644 · Received November 5, 2025

    Report

    Report Number
    9610595-2025-29580
    Event Type
    Malfunction
    Date Received
    November 5, 2025
    Date of Event
    October 1, 2025
    Report Date
    December 16, 2025
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE FINAL INVESTIGATION AND CORRECTION TO H6. UPDATED FIELDS: D8, H2, H3, H4, H6, H11. CORRECTED FIELDS: D10, H6 (F2601, A090208, A190501, A180306, A090206, G04080, G04093, G04034, C0703, C13, D12 REMOVED). 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: NOZZLE HAS FOREIGN OBJECTS, NO IMAGE. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE ROOT CAUSE FOR THE FOREIGN MATTER REMAINING IN THE EQUIPMENT COULD NOT BE DETERMINED. HOWEVER, DUE TO CORROSION ON SCOPE CONNECTOR, IMAGE NOISE OCCURRED AND THE IMAGE COULD NOT BE SEEN. THE LEGAL MANUFACTURE REVIEWED THE CUSTOMER PROVIDED THE CLEANING DISINFECTION AND STERILIZATION (CDS) PROCESSES WHERE NO OBVIOUS DEVIATIONS FROM INSTRUCTIONS FOR USE (IFU) WERE IDENTIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THE EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE HAD IMAGE NOISE. THE ISSUE OCCURRED DURING SET UP / INSPECTION FOR USE (DURING SET UP IN ROOM / BEFORE PATIENT IN ROOM). THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2677890 EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-HQ290

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown