BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III XENON LIGHT SOURCE

    MDR report key: 17770066 · Received September 18, 2023

    Report

    Report Number
    3002808148-2023-09992
    Event Type
    Malfunction
    Date Received
    September 18, 2023
    Date of Event
    August 22, 2023
    Report Date
    January 19, 2024
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    NWB
    UDI-DI
    04953170298868
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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. IT HAS BEEN OVER NINE (9) YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THREE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT, BUT NO RESPONSE WAS RECEIVED FROM THE CUSTOMER. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    D2: ADDITIONAL PROCODES FDS, FDF. THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. TROUBLESHOOTING WAS PERFORMED TO ENSURE HEAT SYNC GREASE WAS APPLIED PROPERLY. VERIFIED THAT AN OLYMPUS LAMP WAS NOT IN USE AND INSTRUCTED TO OBTAIN AN OLYMPUS XENON LAMP PART NUMBER MAJ-1817. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY. THREE ATTEMPTS WERE PERFORMED TO OBTAIN ADDITIONAL INFORMATION, BUT NO RESPONSE WAS RECEIVED FROM THE CUSTOMER.

    Description of Event or Problem · 0

    CUSTOMER REPORTED TO OLYMPUS THAT DURING A PROCEDURE THE MAIN LAMP ON THE EVIS EXERA III XENON LIGHT SOURCE WENT OUT AND THE SPARE LAME CAME ON AND GAVE AN E102 ERROR CODE. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE AND THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2145419 EVIS EXERA III XENON LIGHT SOURCE XENON LIGHT SOURCE NWB SHIRAKAWA OLYMPUS CO., LTD. CLV-190 04953170298868

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown