BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE

    MDR report key: 25163159 · Received May 13, 2026

    Report

    Report Number
    3002808148-2026-15777
    Event Type
    Malfunction
    Date Received
    May 13, 2026
    Date of Event
    February 23, 2026
    Report Date
    May 13, 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. BASED ON THE RESULTS OF THE INVESTIGATION AND HISTORICAL DATA, REASONABLY KNOWN INFORMATION SUGGESTS PROBABLE CAUSES SUCH AS ELECTRICAL PROBLEMS SUCH AS OPEN CIRCUIT, SHORT CIRCUIT, OR SIGNAL LOSS, WITHOUT ANY DESIGN OR MANUFACTURING ISSUE . THE MOST PROBABLE CAUSE OF THIS COMPLAINT IS 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 EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE DID NOT PRODUCT AN IMAGE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258561 EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE BRONCHOFIBERVIDEOSCOPE PSV SHIRAKAWA OLYMPUS CO., LTD. BF-UC190F NA 04953170399831

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown