BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE

    MDR report key: 25225449 · Received May 19, 2026

    Report

    Report Number
    3002808148-2026-16913
    Event Type
    Malfunction
    Date Received
    May 19, 2026
    Report Date
    May 19, 2026
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    PSV
    PMA / PMN Number
    K183525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. BASED ON THE RESULTS OF THE INVESTIGATION, THE PROBABLE CAUSE OF THE IDENTIFIED FAILURES COULD NOT BE ESTABLISHED, AS THE INVESTIGATION FINDINGS DID NOT LEAD TO A CLEAR CONCLUSION REGARDING THE CAUSE OF THE REPORTED ADVERSE EVENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE. DATE OF EVENT IS UNKNOWN. ADDITIONAL INFORMATION WILL BE PROVIDED IF AVAILABLE.

    Description of Event or Problem · 0

    DURING THE DEVICE EVALUATION, A CHIP WAS FOUND ON THE DISTAL END OF THE BRONCHOFIBERVIDEOSCOPE, ALONG WITH DETACHMENT OF THE ADHESIVE ON THE A-RUBBER. THERE WAS NO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358330 EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE BRONCHOFIBERVIDEOSCOPE PSV SHIRAKAWA OLYMPUS CO., LTD. BF-UC190F

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown