BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RHINO-LARYNGO VIDEOSCOPE

    MDR report key: 25107906 · Received May 6, 2026

    Report

    Report Number
    3002808148-2026-14715
    Event Type
    Malfunction
    Date Received
    May 6, 2026
    Date of Event
    April 24, 2026
    Report Date
    May 6, 2026
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    EOB
    UDI-DI
    04953170310447
    PMA / PMN Number
    K221638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    NURSE
    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THE RHINO-LARYNGO VIDEOSCOPE PROTECTIVE COATING ON THE TIP WAS STARTING TO UNRAVEL. THE EVENT OCCURRED DURING SET UP IN ROOM / BEFORE PATIENT IN ROOM. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570136 RHINO-LARYNGO VIDEOSCOPE RHINO-LARYNGO VIDEOSCOPE EOB SHIRAKAWA OLYMPUS CO., LTD. ENF-VH NA 04953170310447

    Patients

    Seq Age Sex Outcome Treatment
    1