BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RHINO-LARYNGO VIDEOSCOPE

    MDR report key: 25244456 · Received May 21, 2026

    Report

    Report Number
    3002808148-2026-17321
    Event Type
    Malfunction
    Date Received
    May 21, 2026
    Date of Event
    March 20, 2026
    Report Date
    May 21, 2026
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    EOB
    PMA / PMN Number
    K061313
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. BASED ON THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE OF THE DISTAL END COVER AND THE SWITCH COVER HAVING ADHESIVE RESIDUE WAS UNABLE TO BE IDENTIFIED. 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 RHINOLARYNGO VIDEOSCOPE EXHIBITED THAT THE DISTAL END COVER HAD ADHESIVE RESIDUE, AND THE SWITCH COVER HAD ADHESIVE RESIDUE, TOO. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367290 RHINO-LARYNGO VIDEOSCOPE RHINO-LARYNGO VIDEOSCOPE EOB SHIRAKAWA OLYMPUS CO., LTD. ENF-VT2

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown