BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALOGEN LIGHT SOURCE

    MDR report key: 25116682 · Received May 7, 2026

    Report

    Report Number
    3002808148-2026-14878
    Event Type
    Malfunction
    Date Received
    May 7, 2026
    Date of Event
    February 4, 2026
    Report Date
    May 7, 2026
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FCQ
    UDI-DI
    04953170024429
    PMA / PMN Number
    K981543
    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 THE ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: LIGHT SOURCE FAILED TO ILLUMINATE, WHICH WAS ATTRIBUTED TO A WORN LAMP SOCKET. THE MOST PROBABLE CAUSE OF THE FAILURE IS KNOWN INHERENT RISK OF THE DEVICE. 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 DURING DEVICE EVALUATION THAT THE HALOGEN LIGHT SOURCE FAILED TO ILLUMINATE, WHICH WAS ATTRIBUTED TO A WORN LAMP SOCKET. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192197 HALOGEN LIGHT SOURCE HALOGEN LIGHT SOURCE FCQ SHIRAKAWA OLYMPUS CO., LTD. CLH-250 04953170024429

    Patients

    Seq Age Sex Outcome Treatment
    1