BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISERA S VIDEO SYSTEM CENTER

    MDR report key: 24973462 · Received April 23, 2026

    Report

    Report Number
    3002808148-2026-12920
    Event Type
    Malfunction
    Date Received
    April 23, 2026
    Date of Event
    September 11, 2025
    Report Date
    April 23, 2026
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    EOB
    PMA / PMN Number
    K243380
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: THE MOST PROBABLE CAUSE OF THE MALFUNCTION IS TRACED TO COMPONENT FAILURE. 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 OBSERVED THAT DURING THE DEVICE EVALUATION, THE VIDEO SYSTEM CENTER HAD E247 ERROR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569426 VISERA S VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER EOB SHIRAKAWA OLYMPUS CO., LTD. OTV-S500

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown