BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISERA ELITE XENON LIGHT SOURCE

    MDR report key: 17830631 · Received September 27, 2023

    Report

    Report Number
    3002808148-2023-10473
    Event Type
    Malfunction
    Date Received
    September 27, 2023
    Report Date
    November 21, 2023
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    NWB
    UDI-DI
    04953170301995
    PMA / PMN Number
    K111425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. NEW INFORMATION ADDED TO THE FOLLOWING FIELDS: A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER TEN (10) YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: DUE TO MALFUNCTION OF THE EXHAUST HEAT FAN. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    D2: ADDITIONAL PRODUCT CODES HET, EOB, EOQ, FGB, AND GCJ. THE DEVICE WAS RETURNED AND EVALUATED, AND THE CUSTOMER'S ALLEGATION WAS CONFIRMED. THE DEVICE EVALUATION FOUND THERE WAS AN EXHAUST HEAT ERROR DUE TO MALFUNCTION OF THE EXHAUST FAN. ADDITIONALLY, THE LAMP HOUSE SIDE COOLING FAN DOES NOT ROTATE AND ERROR CODE E101 OCCURRED, THE OUTPUT CONNECTOR (LIGHT GUIDE CONNECTION PART) BECAME LOOSE DUE TO WEAR, AND THE LAMP CONSUMPTION DECREASED IN LIGHT INTENSITY. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, THE VISERA ELITE XENON LIGHT SOURCE WAS HAVING AN EXHAUST HEAT ERROR DUE TO A MALFUNCTION OF THE EXHAUST FAN. THE ISSUE WAS FOUND DURING INSPECTION PRIOR TO USE, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTS OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316348 VISERA ELITE XENON LIGHT SOURCE XENON LIGHT SOURCE NWB SHIRAKAWA OLYMPUS CO., LTD. CLV-S190 04953170301995

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown