BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE

    MDR report key: 24895730 · Received April 16, 2026

    Report

    Report Number
    3002808148-2026-11679
    Event Type
    Malfunction
    Date Received
    April 16, 2026
    Report Date
    April 24, 2026
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    PSV
    PMA / PMN Number
    K183525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. ADDITIONAL INFORMATION: B5. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE OF SIGNIFICANT IMAGE LOSS WAS NOT CONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION, AND SINCE THE DEVICE MALFUNCTION WAS NOT CONFIRMED DURING EVALUATION, THE DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. 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 ONCE THE INVESTIGATION IS COMPLETE OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS SUPPLIED BY THE CUSTOMER. THE INCIDENT WAS IDENTIFIED AFTER DECONTAMINATING THE ENDOSCOPE AT THE TIME OF STORAGE. THERE WERE NO COMPLICATIONS FOR THE PATIENT. ONLY EXTERNAL DAMAGE TO THE ENDOSCOPE WAS OBSERVED AFTER IT HAD DRIED AND PRIOR TO STORAGE IN THE CABINET WITH A SANITARY BARRIER. SURGICAL PROCEDURE WAS NOT PROLONGED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER DECONTAMINATION, AT THE TIME OF STORAGE, THE BRONCHO FIBER VIDEOSCOPE EXHIBITED SIGNIFICANT IMAGE LOSS. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553166 EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE BRONCHOFIBERVIDEOSCOPE PSV SHIRAKAWA OLYMPUS CO., LTD. BF-UC190F

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown