BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALOGEN LIGHT SOURCE

    MDR report key: 17201167 · Received June 26, 2023

    Report

    Report Number
    3002808148-2023-06380
    Event Type
    Malfunction
    Date Received
    June 26, 2023
    Date of Event
    May 29, 2023
    Report Date
    August 11, 2023
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FAJ
    UDI-DI
    04953170024528
    PMA / PMN Number
    K993041
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION, AND THE CUSTOMER'S ALLEGATION WAS CONFIRMED; DUE TO A FAULTY TRANSFORMER UNIT. THE ADDITIONAL EVALUATION FINDINGS ARE AS FOLLOWS: THE WASHER UNDER THE SCREW ON REAR PANEL WAS MISSING, AND THE LAMP HARNESS WAS DEFORMED. THE INVESTIGATION IS ONGOING, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THAT THE EVENT OCCURRED DUE TO A FAULTY TRANSFORMER UNIT. HOWEVER, THE DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED. THE LAMP WAS FOUND TO BE A THIRD PARTY LAMP. OLYMPUS ALWAYS RECOMMENDS TO USE OLYMPUS MD-151 HALOGEN LAMP. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE OLYMPUS FIELD SERVICE ENGINEER REPORTED (ON BEHALF OF THE CUSTOMER) THAT THE HALOGEN LIGHT SOURCE LAMP DOES NOT LIGHT. THE ISSUE WAS FOUND DURING MAINTENANCE. THERE WERE NO REPORTS OF PATIENT HARM AND NO PROCEDURAL INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1453861 HALOGEN LIGHT SOURCE HALOGEN LIGHT SOURCE FAJ SHIRAKAWA OLYMPUS CO., LTD. CLK-4 04953170024528

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown