BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III XENON LIGHT SOURCE

    MDR report key: 20355856 · Received October 2, 2024

    Report

    Report Number
    3002808148-2024-09548
    Event Type
    Malfunction
    Date Received
    October 2, 2024
    Date of Event
    September 10, 2024
    Report Date
    October 29, 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
    PA, US
    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. CORRECTION: (G2 ¿ REPORT SOURCE): FOREIGN; WAS SELECTED INADVERTENTLY AND DOES NOT APPLY TO THE EVENT. NEW INFORMATION ADDED TO THE FOLLOWING FIELDS: D8, H3, H4, H6. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER THREE (3) YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE INVESTIGATION RESULTS, ERROR CODE B30, COULD NOT BE IDENTIFIED. ROOT CAUSE COULD NOT BE DETERMINED. ACCORDING TO QIR, FAULTY SCOPE SOCKET WAS CONFIRMED. WE, THEREFORE, SURMISED THAT PHENOMENON ¿ERROR CODE B30¿ OCCURRED BECAUSE ELECTRICAL COMMUNICATION WAS NOT PERFORMED PROPERLY DUE TO FAULTY SCOPE SOCKET. THE EVENTS CAN BE DETECTED AND PREVENTED IN ACCORDANCE WITH THE FOLLOWING SECTIONS OF THE INSTRUCTIONS FOR INSTRUCTIONS FOR USE: ¿LABELING REVIEW: NOT APPLICABLE BECAUSE THE MALFUNCTION WAS NOT CAUSED BY A MISUSE OF USERS.¿ OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICE EVALUATION IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE EVIS EXERA III XENON LIGHT SOURCE EXHIBITED ERROR CODE B30. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2017345 EVIS EXERA III XENON LIGHT SOURCE XENON LIGHT SOURCE NWB SHIRAKAWA OLYMPUS CO., LTD. CLV-190 04953170298868

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown