BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISERA ELITE III VIDEO SYSTEM CENTER

    MDR report key: 24913178 · Received April 17, 2026

    Report

    Report Number
    3002808148-2026-12018
    Event Type
    Malfunction
    Date Received
    April 17, 2026
    Date of Event
    March 23, 2026
    Report Date
    May 3, 2026
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    PMA / PMN Number
    K251336
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    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.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE FINAL INVESTIGATION. UPDATED FIELDS: D9, H2, H3, H6, H11. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE WAS CONFIRMED. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, THE MOST PROBABLE CAUSE OF THE REPORTED MALFUNCTION WAS TRACED TO DISCONNECTION IN PRINTED CIRCUIT BOARD (KJO TO KJS) HARNESS. 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 VIDEO SYSTEM CENTER HAD NO IMAGE AND DISPLAYED SCOPE COMMUNICATION ERROR E238 AND E231. THE ISSUE WAS IDENTIFIED DURING DEVICE INSPECTION FOR USE. 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
    533262 VISERA ELITE III VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET SHIRAKAWA OLYMPUS CO., LTD. OTV-S700

    Patients

    Seq Age Sex Outcome Treatment
    1