BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE

    MDR report key: 11222695 · Received January 25, 2021

    Report

    Report Number
    3005580113-2021-00013
    Event Type
    Injury
    Date Received
    January 25, 2021
    Date of Event
    January 11, 2021
    Report Date
    January 25, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PROCODE: FCG KIT, NEEDLE, BIOPSY.

    Description of Event or Problem · 1

    ACCORDING TO THE INITIAL REPORTER, THE TIP OF THE NEEDLE BROKE OFF IN THE PATIENT, IN THE TAIL OF THE PANCREAS. THE NEEDLE PORTION WAS SUCCESSFULLY RETRIEVED AND THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118604 ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE FCG COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention