BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RHINO-LARYNGO VIDEOSCOPE

    MDR report key: 24811687 · Received April 7, 2026

    Report

    Report Number
    3002808148-2026-10189
    Event Type
    Malfunction
    Date Received
    April 7, 2026
    Date of Event
    December 12, 2025
    Report Date
    April 7, 2026
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    EOB
    PMA / PMN Number
    K221638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. IN ADDITION, THE INVESTIGATION FOUND THAT THE GRIP, THE UP/DOWN ANGULATION LEVER PLATE (UD) AND THE UNIVERSAL CORD ARE STICKY. BASED ON THE RESULTS OF THE INVESTIGATION, THE MOST PROBABLE CAUSE OF THIS COMPLAINT IS TRACED TO COMPONENT FAILURE, WHICH IS EXPECTED OR RANDOM COMPONENT FAILURE WITHOUT ANY DESIGN OR MANUFACTURING ISSUE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS OBSERVED THAT DURING THE EVALUATION, THE RHINO-LARYNGO VIDEOSCOPE EXHIBITED THAT THE GRIP, THE UP/DOWN ANGULATION LEVER PLATE (UD) AND THE UNIVERSAL CORD ARE STICKY. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313043 RHINO-LARYNGO VIDEOSCOPE RHINO-LARYNGO VIDEOSCOPE EOB SHIRAKAWA OLYMPUS CO., LTD. ENF-V3

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown