BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RHINO-LARYNGOFIBERSCOPE

    MDR report key: 25234662 · Received May 20, 2026

    Report

    Report Number
    3002808148-2026-17144
    Event Type
    Malfunction
    Date Received
    May 20, 2026
    Date of Event
    April 28, 2026
    Report Date
    May 20, 2026
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    EOB
    PMA / PMN Number
    K011869
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE EVALUATION IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE LARYNGOFIBERSCOPE'S DISTAL END SCOPE WAS BURIED. THE ISSUE WAS FOUND DURING INSTALLATION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294359 RHINO-LARYNGOFIBERSCOPE RHINO-LARYNGOFIBERSCOPE EOB SHIRAKAWA OLYMPUS CO., LTD. ENF-GP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown