BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III BRONCHOVIDEOSCOPE

    MDR report key: 20461803 · Received October 16, 2024

    Report

    Report Number
    9610595-2024-21135
    Event Type
    Malfunction
    Date Received
    October 16, 2024
    Date of Event
    September 30, 2024
    Report Date
    October 16, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    EOQ
    UDI-DI
    04953170335181
    PMA / PMN Number
    K121959
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE EVALUATION IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BRONCHOVIDEOSCOPE HAD A SCOPE COMMUNICATION ERROR E216. THE ISSUE OCCURRED DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2582121 EVIS EXERA III BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ AIZU OLYMPUS CO., LTD. BF-1TH190 04953170335181

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown