BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE

    MDR report key: 24146435 · Received January 22, 2026

    Report

    Report Number
    3002808148-2026-02073
    Event Type
    Malfunction
    Date Received
    January 22, 2026
    Date of Event
    January 9, 2026
    Report Date
    March 11, 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
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS SUBMITTED TO DOCUMENT THE FINDINGS AND CONCLUSIONS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. ADDITIONAL INFORMATION: D9 THE AFFECTED DEVICE WAS RETURNED TO OLYMPUS AMERICA INC. AND UNDERWENT PHYSICAL INSPECTION. FOLLOWING A THOROUGH EVALUATION OF THE RETURNED DEVICE, THE REPORTED MALFUNCTION ¿ SPECIFICALLY, SCOPE COMMUNICATION ERROR ¿ COULD NOT BE CONFIRMED. BASED ON THE FINDINGS OF THE COMPLETED INVESTIGATION, AND GIVEN THAT THE REPORTED DEVICE MALFUNCTION WAS NOT CONFIRMED DURING PHYSICAL EVALUATION OF THE RETURNED DEVICE, A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE ESTABLISHED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THE BRONCHOFIBERVIDEOSCOPE HAD A SCOPE COMMUNICATION ERROR. THE ERROR OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99741 EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE BRONCHOFIBERVIDEOSCOPE PSV SHIRAKAWA OLYMPUS CO., LTD. BF-UC190F 04953170399831

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown