BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALOGEN LIGHT SOURCE

    MDR report key: 23788875 · Received December 12, 2025

    Report

    Report Number
    3002808148-2025-25183
    Event Type
    Malfunction
    Date Received
    December 12, 2025
    Date of Event
    November 16, 2025
    Report Date
    December 12, 2025
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FCQ
    PMA / PMN Number
    TO BE CONFIR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: ELECTRICAL 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

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE LIGHT SOURCE EXHIBITED A DISCONNECTED THERMAL FUSE, LAMP DID NOT LIGHT UP, AND FAN DID NOT ROTATE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2695488 HALOGEN LIGHT SOURCE HALOGEN LIGHT SOURCE FCQ SHIRAKAWA OLYMPUS CO., LTD. CLH-2

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown