BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS X1 VIDEO SYSTEM CENTER

    MDR report key: 22668880 · Received July 30, 2025

    Report

    Report Number
    3002808148-2025-11790
    Event Type
    Malfunction
    Date Received
    July 30, 2025
    Date of Event
    July 23, 2025
    Report Date
    May 19, 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
    MT, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE. THE CUSTOMER CONTACTED OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC) VIA PHONE AND REPORTED THAT CV-1500 IMAGES WERE NOT APPEARING WHEN PRINTING TWO COPIES USING THE OEP-5. OLYMPUS REPRESENTATIVE JILL FERRIS WAS ALSO INVOLVED IN ASSISTING. IT WAS DETERMINED THAT THE RELEASE TIME HAD BEEN SET TO 0.1 SECONDS INSTEAD OF 0.5 SECONDS. ADDITIONALLY, IT WAS FOUND THAT THE CUSTOMER HAD BEEN USING THE MAJ-1918 USB REMOTE INSTEAD OF THE RECOMMENDED MAJ-438 REMOTE FOR PRINTING TWO COPIES WITH THE CV-1500. JILL FERRIS CONFIGURED THE CV-1500 WITH THE MAJ-438 REMOTE. THE DEVICE WILL NOT BE RETURNED TO OLYMPUS FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE FINAL INVESTIGATION. UPDATED FIELDS: D8, H2, H6, H11 THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE WAS NOT CONFIRMED. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, THE MOST PROBABLE CAUSE OF THE COMPLAINT IS NOT ESTABLISHED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SUBJECT DEVICE'S IMAGES WERE NOT DISPLAYING. THE ISSUE OCCURRED DURING A DIAGNOSTIC COLONOSCOPY PROCEDURE, WHICH WAS COMPLETED USING THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237139 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 MAJ-1918| MAJ-438| OEP-5