BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALOGEN LIGHT SOURCE

    MDR report key: 25080596 · Received May 5, 2026

    Report

    Report Number
    3002808148-2026-14416
    Event Type
    Malfunction
    Date Received
    May 5, 2026
    Date of Event
    April 13, 2026
    Report Date
    May 5, 2026
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FCQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HALOGEN LIGHT SOURCE HAD LAMP DISPLAY AND FAN THAT DID NOT WORK. THE ISSUE WAS FOUND DURING A MAINTENANCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54149 HALOGEN LIGHT SOURCE HALOGEN LIGHT SOURCE FCQ SHIRAKAWA OLYMPUS CO., LTD. CLH-2

    Patients

    Seq Age Sex Outcome Treatment
    1