BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISERA PRO VIDEO SYSTEM CENTER

    MDR report key: 23827802 · Received December 17, 2025

    Report

    Report Number
    3002808148-2025-25665
    Event Type
    Malfunction
    Date Received
    December 17, 2025
    Date of Event
    November 11, 2025
    Report Date
    May 7, 2026
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    PMA / PMN Number
    K062049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE WAS CONFIRMED. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THAT THE MALFUNCTION LED TO NOISE IMAGE DUE TO CONTACT ISSUES, CORROSION IN THE VIDEO CONNECTOR SOCKET, AND A LOOSE DIGITAL OUTPUT PORT. 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 THE VIDEO SYSTEM CENTER HAD NOISE PRESENT IN IMAGE. THE ISSUE OCCURRED DURING A THERAPEUTIC DOUBLE-J (WJ) STENT PLACEMENT. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147529 VISERA PRO VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET SHIRAKAWA OLYMPUS CO., LTD. OTV-S7PRO

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown