BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALOGEN LIGHT SOURCE

    MDR report key: 25039160 · Received April 30, 2026

    Report

    Report Number
    3002808148-2026-13923
    Event Type
    Malfunction
    Date Received
    April 30, 2026
    Report Date
    April 30, 2026
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FCQ
    UDI-DI
    04953170024528
    PMA / PMN Number
    K993041
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT DATE IS UNKNOWN AND WILL BE PROVIDED IF RECEIVED. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, THE MOST PROBABLE CAUSE OF THE MALFUNCTION IS 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

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE HALOGEN LIGHT SOURCE LAMP WAS NOT GETTING ON. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1103342 HALOGEN LIGHT SOURCE HALOGEN LIGHT SOURCE FCQ SHIRAKAWA OLYMPUS CO., LTD. CLK-4 04953170024528

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown