BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II XENON LIGHT SOURCE

    MDR report key: 19220010 · Received May 1, 2024

    Report

    Report Number
    3002808148-2024-04036
    Event Type
    Malfunction
    Date Received
    May 1, 2024
    Report Date
    June 26, 2024
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    NWB
    UDI-DI
    04953170215544
    PMA / PMN Number
    K133538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION, ASSOCIATED H6 CODING AN UPDATE TO H2, H3 AND H4. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE FACTS OBTAINED IN THE INVESTIGATION, IT IS LIKELY THAT A SCOPE LAMP ERROR OCCURRED DUE TO A SPARE LAMP FAILURE. HOWEVER, THE ROOT CAUSE COULD NOT BE IDENTIFIED. OLYMPUS WILL CONTINUE TO MONITOR 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 REPORTED, THE LIGHT SOURCE HAD A SCOPE LAMP ERROR. IT IS UNKNOWN WHEN THE ISSUE OCCURRED. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2143899 EVIS EXERA II XENON LIGHT SOURCE XENON LIGHT SOURCE NWB SHIRAKAWA OLYMPUS CO., LTD. CLV-180 04953170215544

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown