BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS X1 VIDEO SYSTEM CENTER

    MDR report key: 21568352 · Received March 10, 2025

    Report

    Report Number
    3002808148-2025-04254
    Event Type
    Malfunction
    Date Received
    March 10, 2025
    Report Date
    August 5, 2025
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    PMA / PMN Number
    K222861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE FINAL INVESTIGATION. UPDATED FIELDS: B5, D4, D8, H2, H3, H4, H6, H11 THE DEVICE WAS EVALUATED BY A FIELD SERVICE ENGINEER AND THE CUSTOMER'S MALFUNCTION WAS CONFIRMED. IN ADDITION, THE FOLLOWING REPORTABLE MALFUNCTIONS WERE IDENTIFIED DURING THE DEVICE EVALUATION: RESETTING THE OIP ELEMENT RESULTED IN MODIFIED SETTINGS AND PARAMETER INSTALLATION. BASED ON THE RESULTS OF THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. 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 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 CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SUBJECT DEVICE HAD NO IMAGE ON THE TRANSFER SCREEN. THE ISSUE HAD OCCURRED DURING SET UP / INSPECTION FOR USE (DURING SET UP IN ROOM / BEFORE PATIENT IN ROOM). THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337143 EVIS X1 VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET SHIRAKAWA OLYMPUS CO., LTD. CV-1500

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown