BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE

    MDR report key: 24824235 · Received April 8, 2026

    Report

    Report Number
    3002808148-2026-10467
    Event Type
    Malfunction
    Date Received
    April 8, 2026
    Date of Event
    December 19, 2025
    Report Date
    April 8, 2026
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    PSV
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. BASED ON THE RESULTS OF THE INVESTIGATION, PROBABLE CAUSES CONSIDERED INCLUDE DAMAGE TO PARTS DUE TO WEAR, DETERIORATION, DEFORMATION, OR SOME FORM OF PHYSICAL STRESS. THE MOST PROBABLE CAUSE OF THIS COMPLAINT IS EXPECTED OR RANDOM COMPONENT FAILURE, WITH NO DESIGN OR MANUFACTURING ISSUES 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

    DURING THE DEVICE EVALUATION, IT WAS FOUND THAT THE DISTAL END WAS CHIPPED AND THE FORCEPS CHANNEL PORT HAD CORROSION ON THE BRONCHOVIDEOSCOPE. NO PATIENTS WERE INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93844 EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE BRONCHOFIBERVIDEOSCOPE PSV SHIRAKAWA OLYMPUS CO., LTD. BF-UC290F

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown