BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III BRONCHOVIDEOSCOPE

    MDR report key: 20800454 · Received November 27, 2024

    Report

    Report Number
    9610595-2024-40268
    Event Type
    Malfunction
    Date Received
    November 27, 2024
    Date of Event
    November 1, 2024
    Report Date
    March 17, 2025
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    EOQ
    PMA / PMN Number
    K121959
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATE TO: H2, H3, H4 AND H6. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE CUSTOMER ALLEGATION WAS CONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION, A ROOT CAUSE COULD NOT BE IDENTIFIED. 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

    IT WAS REPORTED THAT WHEN USING THE SUBJECT DEVICE IT WAS SHOWING A SCOPE COMMUNICATION ERROR. THE ISSUE OCCURRED DURING SETUP FOR AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

    Description of Event or Problem · 0

    IT WAS REPORTED, THAT WHEN USING THE SUBJECT DEVICE. IT WAS SHOWING, A SCOPE COMMUNICATION ERROR. THE ISSUE OCCURRED, DURING SETUP. FOR AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826844 EVIS EXERA III BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ AIZU OLYMPUS CO., LTD. BF-H190

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown