BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III XENON LIGHT SOURCE

    MDR report key: 20465505 · Received October 16, 2024

    Report

    Report Number
    3002808148-2024-10055
    Event Type
    Malfunction
    Date Received
    October 16, 2024
    Date of Event
    October 3, 2024
    Report Date
    November 6, 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
    ME, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE APPROVED FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, AND SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION, THE DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    IN SPEAKING WITH THE OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC), THE CUSTOMER REPORTED THAT THE XENON LIGHT SOURCE EXPERIENCED THAT THE IMAGE WAS TOO BRIGHT AND THE BRIGHTNESS WAS NOT AUTO ADJUSTING. THROUGH TROUBLESHOOTING THE NAJ-1941 AND MAJ-1933 LIGHT SOURCE CABLES WERE DISCONNECTED AND RECONNECTED. THEY WERE THEN BOTH TESTED WHICH AS A RESULT IT APPEARED TO BE AUTO ADJUSTING. THE ERROR DID NOT EXIST AFTER THE DOCTOR TESTED THE DEVICE, ISSUE WAS RESOLVED. THE DEVICE IS NOT EXPECTED TO BE RETURNED TO OLYMPUS FOR EVALUATION. THE DEVICE EVALUATION IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC), THAT THE XENON LIGHT SOURCE WAS TOO BRIGHT AND HE COULD NOT SEE THE IMAGE IN DETAIL. THE ISSUE OCCURRED AFTER THE EQUIPMENT HAD BEEN REORGANIZED ON THE CART. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC), THAT THE XENON LIGHT SOURCE IS TOO BRIGHT AND CANNOT SEE THE IMAGE IN DETAIL. IT IS UNKNOWN WHEN THE ISSUE OCCURRED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1248677 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