BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISERA RHINO-LARYNGO VIDEOSCOPE

    MDR report key: 25001875 · Received April 27, 2026

    Report

    Report Number
    3002808148-2026-13412
    Event Type
    Malfunction
    Date Received
    April 27, 2026
    Report Date
    April 27, 2026
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    EOB
    PMA / PMN Number
    K061313
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 CAUSE FOR THE REPORTED FAILURE COULD NOT BE IDENTIFIED; HOWEVER, THE MOST PROBABLE CAUSE IS PRESUMED TO BE USAGE STRESS OR EXTERNAL FACTORS. 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

    DURING THE DEVICE EVALUATION, PEELING OF THE PLATING ON THE DISTAL END OF THE VIDEOSCOPE WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279104 VISERA RHINO-LARYNGO VIDEOSCOPE RHINO-LARYNGO VIDEOSCOPE EOB SHIRAKAWA OLYMPUS CO., LTD. ENF-V2

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown