BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III BRONCHOVIDEOSCOPE

    MDR report key: 22174998 · Received June 10, 2025

    Report

    Report Number
    9610595-2025-10737
    Event Type
    Malfunction
    Date Received
    June 10, 2025
    Date of Event
    May 19, 2025
    Report Date
    November 4, 2025
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    EOQ
    UDI-DI
    04953170434990
    PMA / PMN Number
    K201758
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE FINAL INVESTIGATION. UPDATES FIELDS: B5, G3, H2, H3, H4, H6 AND H11. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE CUSTOMER'S ALLEGATION COULD NOT BE CONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION, AND SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION, THE DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S UPDATED INVESTIGATION TO THE PREVIOUSLY SUBMITTED INVESTIGATION RESULTS AND AN UPDATE TO D9. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY NO IMAGE WAS DUE TO DEFORMATION OF THE DISTAL END, THE SPECIFIED RESOLVING POWER WAS NOT OBTAINED. THE MOST PROBABLE CAUSE OF THIS COMPLAINT IS A RANDOM COMPONENT FAILURE WITHOUT ANY DESIGN OR MANUFACTURING ISSUE. THE ROOT CAUSE COULD NOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED, THE BRONCHOVIDEOSCOPE JAD NO IMAGE. THE EVENT OCCURRED DURING AN UNSPECIFIED DIAGNOSTIC PROCEDURE AND THERE WAS A DELAY REPORTED IN THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1266029 EVIS EXERA III BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ AIZU OLYMPUS CO., LTD. BF-XP190 04953170434990

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown