BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III XENON LIGHT SOURCE

    MDR report key: 20023585 · Received August 21, 2024

    Report

    Report Number
    3002808148-2024-07812
    Event Type
    Malfunction
    Date Received
    August 21, 2024
    Date of Event
    March 14, 2024
    Report Date
    September 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
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE EVALUATION 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. CORRECTED FIELDS: B5, E2 AND E3. ADDITIONAL INFORMATION ADDED TO FIELDS: H2, H3, H4 AND 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 TEN (10) YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, THE ISSUE WAS LIKELY THE RESULT OF A FAULTY POWER SWITCH. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    POWER/FRONT PANEL/SWITCH PROBLEMS POWER/FRONT PANEL/SWITCH PROBLEMS POWER SWITCH IS STUCK ITS PUSHED INSIDE IT WONT COME OUT SENDING DUPLICATE REVIEW FOR (B)(6) TO MANAGEMENT TEAM. (B)(4)/MBH/416408 14AUG2024. UPDATE PER (B)(4): FOR THE FOLLOWING TWO COMPLAINT REPORTS, I AGREE THAT THESE REPORTS ARE RELATED TO DUPLICATES BECAUSE THE QIR RESULTS AND UR HAVE THE SAME INFORMATION, AND I CONFIRM THAT (B)(6) IS CLOSED AS A DUPLICATE REPORT. (B)(4)/MBH/416408 15AUG2024 ADDING SO# (B)(4) FROM THE DUPLICATE COMPLAINT IN SYSTEM SOURCE FIELD. (B)(4)/MBH/416408 15AUG2024 UPDATE: UPDATING IUC CVP3 (POWER/FRONT PANEL/SWITCH PROBLEMS) TO THE IUC CVP322 (POWER SWITCH MALFUNCTION) FROM DUPLICATE TO COMPLAINT FILE. (B)(4)/MBH/416408 15AUG2024. UPDATE PER ESTIMATION THE FUC CVP3225C (POWER SWITCH MECHANISM FAILURE) IS A PAE CODE. PAE NO/YES, TIER 2. (B)(4)/MBH/416408 15AUG2024 UPDATING AWARE DATE FROM 15MAR2024 TO THE DATE WHEN THE ESTIMATOR FOUND THE PAE CODE AS THE NEW AWARENESS DATE OF 13AUG2024. (B)(4)/MBH/416408 15AUG2024.

    Description of Event or Problem · 0

    IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE XENON LIGHT SOURCE EXHIBITED A POWER SWITCH THAT WILL IS STUCK AND IT WILL NOT COME OUT. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2286569 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