BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISERA ELITE III VIDEO SYSTEM CENTER

    MDR report key: 23816552 · Received December 16, 2025

    Report

    Report Number
    3002808148-2025-25499
    Event Type
    Malfunction
    Date Received
    December 16, 2025
    Report Date
    January 14, 2026
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    PMA / PMN Number
    K251336
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE CORRECTION AND THE RESULTS OF THE FINAL INVESTIGATION. UPDATED FIELDS: D8; E1 - INITIAL REPORTER ESTABLISHMENT NAME: MEGA PRIVATE HEALTH SERVICES AND MEDICAL PRODUCTS INDUSTRY AND TRADE INC.; G3; H2; H3; H6 AND H11. CORRECTED FIELD: H8. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE REPORTED FAILURE WAS CONFIRMED. IN ADDITION, THE FOLLOWING REPORTABLE MALFUNCTION WAS IDENTIFIED DURING THE DEVICE EVALUATION: OPTICAL FIBER WAS DEFECTIVE. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: OPTICAL FIBER IS DEFECTIVE. THE MOST PROBABLE CAUSE WAS 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.

    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 THE CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THE VIDEO SYSTEM CENTER EXPERIENCED AN IMAGE FAULT AND E226 ERROR. THIS ISSUE OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2281714 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