BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RHINO-LARYNGO VIDEOSCOPE

    MDR report key: 24933779 · Received April 20, 2026

    Report

    Report Number
    3002808148-2026-12281
    Event Type
    Malfunction
    Date Received
    April 20, 2026
    Date of Event
    January 30, 2026
    Report Date
    April 20, 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 DUE TO CORROSION ON THE ELECTRICAL CONTACT OF THE VIDEO CONNECTOR, A NOISE IMAGE OCCURS. BASED ON THE RESULTS OF THE INVESTIGATION, THE MOST PROBABLE CAUSE OF THE ADDITIONAL REPORTED FAILURE(S) DID NOT LEAD TO A CLEAR CONCLUSION ABOUT THE ROOT CAUSE OF THE REPORTED EVENT. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS OBSERVED THAT DURING THE EVALUATION, THE RHINO-LARYNGO VIDEOSCOPE EXHIBITED THAT DUE TO CORROSION ON THE ELECTRICAL CONTACT OF THE VIDEO CONNECTOR, A NOISE IMAGE OCCURS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420568 RHINO-LARYNGO VIDEOSCOPE RHINO-LARYNGO VIDEOSCOPE EOB SHIRAKAWA OLYMPUS CO., LTD. ENF-VH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown