BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISERA RHINO-LARYNGO VIDEOSCOPE

    MDR report key: 23427616 · Received October 30, 2025

    Report

    Report Number
    3002808148-2025-20441
    Event Type
    Malfunction
    Date Received
    October 30, 2025
    Date of Event
    October 15, 2025
    Report Date
    October 30, 2025
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    EOB
    PMA / PMN Number
    K061313
    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 WAS LIKELY THE CAUSE COULD NOT BE ESTABLISHED. 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 VISERA RHINO-LARYNGO VIDEOSCOPE EXHIBITED FOREIGN OBJECTS ON THE BENDING SECTION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2296368 VISERA RHINO-LARYNGO VIDEOSCOPE RHINO-LARYNGO VIDEOSCOPE EOB SHIRAKAWA OLYMPUS CO., LTD. ENF-V2

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown