BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III BRONCHOVIDEOSCOPE

    MDR report key: 21068409 · Received January 3, 2025

    Report

    Report Number
    9610595-2025-00042
    Event Type
    Malfunction
    Date Received
    January 3, 2025
    Report Date
    March 6, 2025
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    EOQ
    UDI-DI
    04953170342110
    PMA / PMN Number
    K201758
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    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. UPDATED FIELDS: D8, D9, H3, H4, H6, AND H11. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE WAS CONFIRMED. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. 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

    IT WAS REPORTED THE BRONCHOVIDEOSCOPE HAD A SCOPE COMMUNICATION ERROR. THE ISSUE WAS FOUND DURING SET UP BEFORE THE PATIENT WAS IN THE ROOM. THERE WERE NO REPORTS OF PATIENT HARM.

    Description of Event or Problem · 0

    IT WAS REPORTED THE BRONCHOVIDEOSCOPE HAD A SCOPE COMMUNICATION ERROR. THE ISSUE WAS FOUND DURING SET UP BEFORE THE PATIENT WAS IN THE ROOM. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568515 EVIS EXERA III BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ AIZU OLYMPUS CO., LTD. BF-P190 04953170342110

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown