BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ELITE XENON LIGHT SOURCE

    MDR report key: 25302475 · Received May 27, 2026

    Report

    Report Number
    3002808148-2026-18150
    Event Type
    Malfunction
    Date Received
    May 27, 2026
    Date of Event
    March 17, 2026
    Report Date
    May 27, 2026
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    GCT
    PMA / PMN Number
    N/A
    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. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, THE MOST PROBABLE CAUSE OF THE OCCASIONAL IMAGE FLICKERING WAS A RED, BLUE, GREEN (RGB) MALFUNCTION. THE CONCLUSION WAS THAT THE ISSUE 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

    THE CUSTOMER RETURNED THE XENON LIGHT SOURCE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN IDENTIFIED THAT THE DEVICE EXHIBITED OCCASIONAL IMAGE FLICKERING, WHICH WAS DETERMINED TO HAVE BEEN CAUSED BY A RED, BLUE, GREEN (RGB) MALFUNCTION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253698 EVIS LUCERA ELITE XENON LIGHT SOURCE XENON LIGHT SOURCE GCT SHIRAKAWA OLYMPUS CO., LTD. CLV-290SL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown