BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III XENON LIGHT SOURCE

    MDR report key: 20064693 · Received August 26, 2024

    Report

    Report Number
    3002808148-2024-08104
    Event Type
    Malfunction
    Date Received
    August 26, 2024
    Date of Event
    August 14, 2024
    Report Date
    November 11, 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
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF 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 EIGHT (8) YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE CUSTOMER'S COMPLAINT/REPORTABLE MALFUNCTION WAS CONFIRMED. BASED ON THE INVESTIGATION RESULTS, ERROR CODE B30, COULD NOT BE IDENTIFIED. ROOT CAUSE COULD NOT BE IDENTIFIED. ERROR CODE B30 OCCURRED DUE TO SCOPE SOCKET FAILURE. THEREFORE, IT HAS BEEN DETERMINED THAT IT IS NOT A DEFECT CAUSED BY USER MISUSE. THE EVENTS CAN BE DETECTED AND PREVENTED IN ACCORDANCE WITH THE FOLLOWING SECTIONS OF THE INSTRUCTIONS FOR INSTRUCTIONS FOR USE: ¿LABELLING REVIEW: BASED ON THE QIR, IT WAS CONFIRMED THAT ERROR CODE B30 OCCURRED DUE TO SCOPE SOCKET FAILURE. THEREFORE, IT IS DETERMINED THAT IT IS NOT A DEFECT CAUSED BY USER MISUSE.¿ OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED, THE XENON LIGHT SOURCE EXHIBITED A B30 ERROR (SCOPE COMMUNICATION ERROR). THE ISSUE OCCURRED DURING AN UNKNOWN PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270616 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