BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE

    MDR report key: 10918099 · Received November 30, 2020

    Report

    Report Number
    3005580113-2020-00445
    Event Type
    Injury
    Date Received
    November 30, 2020
    Date of Event
    October 28, 2020
    Report Date
    November 30, 2020
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    10827002342818
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME: FCG KIT, NEEDLE, BIOPSY. (B)(4).

    Description of Event or Problem · 1

    THE TIP OF THE NEEDLE BROKE OFF IN THE PATIENT'S LUNG. THE USER WAS ABLE TO RETRIEVE THE NEEDLE PORTION VIA SUCTIONING. NO HARM TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1383874 ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE FCG COOK IRELAND LTD C1755687 10827002342818

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention