BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE

    MDR report key: 25221860 · Received May 19, 2026

    Report

    Report Number
    3002808148-2026-16854
    Event Type
    Malfunction
    Date Received
    May 19, 2026
    Date of Event
    March 26, 2026
    Report Date
    May 19, 2026
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    PSV
    UDI-DI
    04953170399831
    PMA / PMN Number
    K183525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    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: THE MOST PROBABLE CAUSE IS A CAUSE TRACED TO COMPONENT FAILURE, WHICH IS AN EXPECTED OR RANDOM COMPONENT FAILURE WITHOUT ANY DESIGN OR MANUFACTURING ISSUE. 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 ULTRASOUND BRONCHOFIBERVIDEOSCOPE HAD NO IMAGE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9823 EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE BRONCHOFIBERVIDEOSCOPE PSV SHIRAKAWA OLYMPUS CO., LTD. BF-UC190F 04953170399831

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown