BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 24235654 · Received February 2, 2026

    Report

    Report Number
    9610595-2026-10971
    Event Type
    Malfunction
    Date Received
    February 2, 2026
    Date of Event
    July 20, 2025
    Report Date
    May 4, 2026
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE CORRECTION OF H6, AND RESULTS OF DEVICE HISTORY RECORD. UPDATED FIELDS: H6, H11. CORRECTED FIELDS: H6 (E2401, F24, A0506, A0415, A0407, A0404, A0405, A180306, G04140, G04097, G04042, G0405201, G05006, G04037, G04018, G04134, G04129, C19, C0601, C070603, C1502, C070606, D14, D15 REMOVED) A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. 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 DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. BASED ON THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE OF THE EVENT WAS TRACED TO 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

    NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

    Description of Event or Problem · 0

    DURING DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE SCREEN TURNED WHITE WITH NO IMAGE AND DID NOT RETURN TO NORMAL DUE TO DAMAGE TO THE OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89978 EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-HQ290

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown