BEUDAMED
    FDA Adverse Event Summary report: N

    ECHOTIP PROCORE HD ULTRASOUND BIOPSY NEEDLE

    MDR report key: 2982650 · Received February 21, 2013

    Report

    Report Number
    MW5029134
    Date Received
    February 21, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 21, 2013
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING EUS PROCEDURE, FNA NEEDLE BROKE, RETAINING A PORTION OF THE NEEDLE INSIDE OF THE SCOPE. BROKEN NEEDLE WAS RETRIEVED FROM THE SCOPE. THE BROKEN NEEDLE WAS NOT INSERTED INSIDE OF THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75499 ECHOTIP PROCORE HD ULTRASOUND BIOPSY NEEDLE HD ULTRASOUND BIOPSY NEEDLE FCG COOK IRELAND LTD ECHO-HD 19-C C794304

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention