BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RHINO-LARYNGO VIDEOSCOPE

    MDR report key: 25331273 · Received May 29, 2026

    Report

    Report Number
    3002808148-2026-18510
    Event Type
    Malfunction
    Date Received
    May 29, 2026
    Date of Event
    March 24, 2026
    Report Date
    May 29, 2026
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    EOB
    UDI-DI
    04953170310416
    PMA / PMN Number
    K221638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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: MISSING GLUE AROUND LENS DUE TO STRESS AND DEGRADATION PROBLEM. 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

    THE CUSTOMER RETURNED THE RHINO LARYNGO VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATES THAT A MISSING GLUE AROUND LENS WAS FOUND AND EXCESSIVE GLUE AROUND THE LIGHT GUIDE LENS WAS AFFECTING THE IMAGE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22175 RHINO-LARYNGO VIDEOSCOPE RHINO-LARYNGO VIDEOSCOPE EOB SHIRAKAWA OLYMPUS CO., LTD. ENF-V3 04953170310416

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown