BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RHINO-LARYNGOFIBERSCOPE

    MDR report key: 25057184 · Received May 1, 2026

    Report

    Report Number
    3002808148-2026-14118
    Event Type
    Malfunction
    Date Received
    May 1, 2026
    Date of Event
    February 13, 2026
    Report Date
    May 1, 2026
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    EOB
    UDI-DI
    04953170078231
    PMA / PMN Number
    K011869
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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: CAUSE LINKED TO THE DEVICE BUT UNABLE TO TRACE MORE SPECIFICALLY. 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 RHINO LARYNGOFIBERSCOPE WAS RETURNED TO THE OLYMPUS SERVICE CENTER WITH A REPORT OF LEAKING AT THE LIGHT SOURCE. THIS DOES NOT INDICATE A MEDICAL DEVICE REGULATIONS REPORTABLE EVENT. HOWEVER, A REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE OLYMPUS SERVICE CENTER. DURING INSPECTION OF THE DEVICE, LOOSENESS OF THE LIGHT GUIDE COVER GLASS WAS FOUND DUE TO A CAUSE LINKED TO THE DEVICE BUT UNABLE TO TRACE MORE SPECIFICALLY. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125716 RHINO-LARYNGOFIBERSCOPE RHINO-LARYNGOFIBERSCOPE EOB SHIRAKAWA OLYMPUS CO., LTD. ENF-GP 04953170078231

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown