BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALOGEN LIGHT SOURCE

    MDR report key: 16673471 · Received April 4, 2023

    Report

    Report Number
    3002808148-2023-03276
    Event Type
    Malfunction
    Date Received
    April 4, 2023
    Date of Event
    March 6, 2023
    Report Date
    June 8, 2023
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FAJ
    UDI-DI
    04953170024511
    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

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION FROM THE CUSTOMER (SEE UPDATED SECTIONS B5).

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED FOR EVALUATION, THEREFORE THE DEVICE EVALUATION COULD NOT BE COMPLETED AT THIS TIME. THE INVESTIGATION IS ONGOING, AND FOLLOW-UP WITH THE USER FACILITY IS CURRENTLY BEING PERFORMED. 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

    THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE CUSTOMER'S COMPLAINT WAS NOT CONFIRMED. ADDITIONALLY, THE REPAIR CENTER FOUND DUST IN THE UNIT, TWO WASHERS AT THE CHASSIS WERE MISSING, AS WELL AS MULTIPLE SCRATCHES / COSMETIC DAMAGE TO THE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 5 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, IT¿S LIKELY THE PROCEDURE WAS POSTPONED DUE TO THE DEVICE FAILURE THAT THE CUSTOMER EXPERIENCED. HOWEVER, THE ROOT CAUSE OF THE POWER NOT TURNING ON WAS UNABLE TO BE IDENTIFIED, AS THE EVENT WAS UNABLE TO BE REPRODUCED DURING THE DEVICE EVALUATION. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER. THE PATIENT WAS ASKED TO VISIT ANOTHER HOSPITAL; THE PROCEDURE WAS POSTPONED, BUT NO MORE INFORMATION IS KNOWN AS THE PATIENT WAS SHIFTED TO ANOTHER HOSPITAL. THE PATIENT WAS NOT UNDER GENERAL ANESTHESIA UNTIL HE REMAINED IN THE HOSPITAL BEFORE BEING ASKED TO VISIT ANOTHER HOSPITAL.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS THAT DURING A DIAGNOSTIC BRONCHOSCOPY PROCEDURE, THE HALOGEN LIGHT SOURCE DID NOT HAVE ANY POWER. THE INTENDED PROCEDURE WAS POSTPONED AND COMPLETED LATER WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404436 HALOGEN LIGHT SOURCE HALOGEN LIGHT SOURCE FAJ SHIRAKAWA OLYMPUS CO., LTD. CLK-4 04953170024511

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown