BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE

    MDR report key: 11208352 · Received January 21, 2021

    Report

    Report Number
    3005580113-2021-00012
    Event Type
    Injury
    Date Received
    January 21, 2021
    Date of Event
    January 7, 2021
    Report Date
    January 21, 2021
    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

    FCG KIT, NEEDLE, BIOPSY.

    Description of Event or Problem · 1

    ACCORDING TO THE INITIAL REPORTER, THE TIP OF THE NEEDLE BROKE OFF DURING PROCEDURE AND THEY WEREN'T ABLE TO FIND THE NEEDLE. X-RAY WAS PERFORMED AND NOTHING COULD BE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103553 ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE FCG COOK IRELAND LTD C1764397 10827002342818

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention