BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALOGEN LIGHT SOURCE

    MDR report key: 25319459 · Received May 28, 2026

    Report

    Report Number
    3002808148-2026-18355
    Event Type
    Malfunction
    Date Received
    May 28, 2026
    Report Date
    May 28, 2026
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FCQ
    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: THE FAN DOES NOT ROTATE DUE TO A TEMPERATURE FUSE DISCONNECTION 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 HALOGEN LIGHT SOURCE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATES THAT THE FAN DOES NOT ROTATE DUE TO A TEMPERATURE FUSE DISCONNECTION, AND THE LAMP DOES NOT LIGHT UP. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576363 HALOGEN LIGHT SOURCE HALOGEN LIGHT SOURCE FCQ SHIRAKAWA OLYMPUS CO., LTD. CLH-2

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown