BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RHINO-LARYNGOFIBERSCOPE

    MDR report key: 25137827 · Received May 11, 2026

    Report

    Report Number
    9610773-2026-03670
    Event Type
    Malfunction
    Date Received
    May 11, 2026
    Date of Event
    March 14, 2026
    Report Date
    May 11, 2026
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    EOB
    PMA / PMN Number
    K011869
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    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 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

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RHINO LARYNGOFIBERSCOPE ADHESIVE ON THE BENDING SECTION COVER HAD CORROSION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452992 RHINO-LARYNGOFIBERSCOPE RHINO-LARYNGOFIBERSCOPE EOB OLYMPUS WINTER & IBE GMBH ENF-GP

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown