BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISERA ELITE III VIDEO SYSTEM CENTER

    MDR report key: 22988940 · Received September 6, 2025

    Report

    Report Number
    3002808148-2025-14833
    Event Type
    Malfunction
    Date Received
    September 6, 2025
    Date of Event
    July 17, 2025
    Report Date
    November 14, 2025
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    PMA / PMN Number
    K242067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    501

    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.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE FINAL INVESTIGATION. UPDATED FIELDS: D8, D9, H2, H3, H4, H6, H11. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE REPORTED FAILURE WAS CONFIRMED. IN ADDITION, THE FOLLOWING REPORTABLE MALFUNCTIONS WERE IDENTIFIED DURING THE DEVICE EVALUATION: E223 APPEARS IN ERROR LOG AND ALSO APPEARS WHEN A CAMERA HEAD / ENDOSCOPE IS CONNECTED - FAULTY VIDEO CONNECTOR. VIDEO CONNECTOR SOCKET IS WORN OUT, THERE IS NOISE IN THE IMAGE. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: THE ERROR 213, 226 AND THE NO IMAGE WERE DUE TO THE FAULTY VIDEO CONNECTOR SOCKET. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SUBJECT DEVICE DISPLAYED ERROR E213, EXPERIENCED RESTARTS, AND FAILED TO PROVIDE AN IMAGE FOR USE DURING THE OPERATION. ERROR E226 WAS ALSO OBSERVED. THE ISSUE OCCURRED DURING A THERAPEUTIC LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. THE PROCEDURE WAS COMPLETED USING AN OLYMPUS BACK-UP DEVICE. NO PATIENT HARM WAS REPORTED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2093972 VISERA ELITE III VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET SHIRAKAWA OLYMPUS CO., LTD. OTV-S700

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown