BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZEPHYR ENDOBRONCHIAL VALVE (EBV)

    MDR report key: 11773762 · Received May 4, 2021

    Report

    Report Number
    3007797756-2021-00081
    Event Type
    Malfunction
    Date Received
    May 4, 2021
    Date of Event
    April 5, 2021
    Report Date
    May 4, 2021
    Product Code
    NJK
    UDI-DI
    00811907030621
    PMA / PMN Number
    P180002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2021, WHILE SIZING THE LB6 AIRWAY WITH EDC 4.0-J CATHETER, A SIZING TAB FELL OFF THE EDC INTO THE AIRWAY WHEN THE CATHETER WAS PULLED INTO THE BRONCHOSCOPE. THE SIZING TAB WAS REMOVED FROM AIRWAY VIA BRONCHOSCOPE SUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668198 ZEPHYR ENDOBRONCHIAL VALVE (EBV) ENDOBRONCHIAL VALVE NJK ZEPHYR 4.0-J EDC 505145-V5.0 00811907030621

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention