BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RHINO-LARYNGO VIDEOSCOPE

    MDR report key: 25186770 · Received May 15, 2026

    Report

    Report Number
    3002808148-2026-16257
    Event Type
    Malfunction
    Date Received
    May 15, 2026
    Date of Event
    January 20, 2026
    Report Date
    May 15, 2026
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    EOB
    PMA / PMN Number
    K221638
    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: UNIVERSAL CORD IS STICKY AND LIGHT GUIDE COVER GLASS HAS CORROSION. 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 RHINO LARYNGO VIDEOSCOPE EXHIBITED CORROSION ON LIGHT GUIDE COVER AND STICKY UNIVERSAL CORD. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82783 RHINO-LARYNGO VIDEOSCOPE RHINO-LARYNGO VIDEOSCOPE EOB SHIRAKAWA OLYMPUS CO., LTD. ENF-VH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown