BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS X1 VIDEO SYSTEM CENTER

    MDR report key: 23848662 · Received December 19, 2025

    Report

    Report Number
    3002808148-2025-25893
    Event Type
    Malfunction
    Date Received
    December 19, 2025
    Date of Event
    November 24, 2025
    Report Date
    March 3, 2026
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    UDI-DI
    04953170414596
    PMA / PMN Number
    K222861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE FINAL INVESTIGATION. UPDATED FIELDS: H2, H6, H11. THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR INSPECTION, AND THE REPORTED FAILURE WAS CONFIRMED. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: NO IMAGE DUE TO INCORRECT CABLE CONNECTION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER CONTACTED OLYMPUS TECHNICAL ASSISTANCE SUPPORT (TAC) VIA PHONE. TROUBLESHOOTING WAS PERFORMED, INCLUDING VERIFICATION OF THE 3G-SDI (SERIAL DIGITAL INTERFACE) SIGNAL PATH AND INSTRUCTION TO RUN AN ADDITIONAL SDI CABLE FROM THE CLONE OUT PORT ON THE OEV-262H TO THE 3G-SDI IN ON THE SECONDARY OEV-321UH MONITOR. THE CUSTOMER INFORMED TAC OF THE EVENT. THE DEVICE WILL NOT BE RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VIDEO SYSTEM CENTER HAD NO IMAGE. THE ISSUE WAS FOUND DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2243160 EVIS X1 VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET SHIRAKAWA OLYMPUS CO., LTD. CV-1500 04953170414596

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown