BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE

    MDR report key: 24906188 · Received April 16, 2026

    Report

    Report Number
    3002808148-2026-11885
    Event Type
    Malfunction
    Date Received
    April 16, 2026
    Date of Event
    January 5, 2026
    Report Date
    April 16, 2026
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    PSV
    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 THE CURVED RUBBER BONDING AREA IS CHIPPED, THE ADHESIVE ON THE BENDING SECTION COVER (A-RUBBER) HAS A CHIP, THE ADHESIVE ON BENDING SECTION COVER (A-RUBBER) IS DETACHED AND THE ADHESIVE ON THE BENDING SECTION COVER (A-RUBBER) HAS CORROSION. BASED ON THE RESULTS OF THE INVESTIGATION, THE MOST PROBABLE CAUSES SUCH AS DAMAGE OF PARTS DUE TO DETERIORATION/ DEFORMATION/ SOME KIND OF PHYSICAL STRESS, 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. 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 ULTRASONIC BRONCHOFIBERVIDEOSCOPE EXHIBITED THAT THE CURVED RUBBER BONDING AREA IS CHIPPED, THE ADHESIVE ON THE BENDING SECTION COVER (A-RUBBER) HAS A CHIP, THE ADHESIVE ON BENDING SECTION COVER (A-RUBBER) IS DETACHED AND THE ADHESIVE ON THE BENDING SECTION COVER (A-RUBBER) HAS CORROSION. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80659 EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE BRONCHOFIBERVIDEOSCOPE PSV SHIRAKAWA OLYMPUS CO., LTD. BF-UC290F

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown