BEUDAMED
    FDA Adverse Event Injury Summary report: N

    19 GAUGE SHARK CORE NEEDLE SYSTEM

    MDR report key: 6113896 · Received November 16, 2016

    Report

    Report Number
    MW5066183
    Event Type
    Injury
    Date Received
    November 16, 2016
    Date of Event
    November 2, 2016
    Report Date
    November 4, 2016
    Manufacturer
    COVIDIEN/MEDTRONIC
    Product Code
    FCG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A 19 GAUGE SHARE CORE NEEDLE WAS PASSED THROUGH A LINEAR EUS SCOPE AND A CORE BIOPSY WAS TAKEN. WHEN THE NEEDLE WAS PULLED BACK FOLLOWING THE BIOPSY, THE HANDLE DETACHED FROM THE NEEDLE SHEATH. CORE BIOPSY WAS OBTAINED. NO HARM TO PATIENT OR STAFF. MANUFACTURER: PLEASE NOTE THAT WE DO NOT SEND PRODUCTS TO THE MANUFACTURER, BUT YOU MAY ARRANGE FOR PICK-UP BY CALLING MY NUMBER BELOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758366 19 GAUGE SHARK CORE NEEDLE SYSTEM BIOPSY NEEDLE FCG COVIDIEN/MEDTRONIC DSL-19-01 B000000166

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention