BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE

    MDR report key: 8889106 · Received August 13, 2019

    Report

    Report Number
    3005580113-2019-00243
    Event Type
    Injury
    Date Received
    August 13, 2019
    Date of Event
    July 25, 2019
    Report Date
    August 13, 2019
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME: FCG KIT, NEEDLE, BIOPSY. PROCODE: FCG.

    Description of Event or Problem · 1

    AS REPORTED TO CUSTOMER RELATIONS "THEY STARTED USING AN OLYMPUS NEEDLE. AFTER USING THAT OLYMPUS NEEDLE, THEY DECIDED TO USE A COOK NEEDLE. TOWARD THE END, ONCE THEY WERE DONE WITH THE PROCEDURE, THE PATIENT WAS HAVING SOME BLEEDING WHILE BEING SUCTIONED AND CLEANED UP. IT COULD NOT BE DETERMINED WHICH NEEDLE CAUSED THE BLEEDING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681662 ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE FCG COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention