BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP PROCORE

    MDR report key: 3021298 · Received March 21, 2013

    Report

    Report Number
    3021298
    Event Type
    Malfunction
    Date Received
    March 21, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 21, 2013
    Manufacturer
    COOK, INC.
    Product Code
    FCG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN PLACED NEEDLE THROUGH SCOPE, DID 3 PASSES, PULLED NEEDLE BACK, TOOK NEEDLE OUT OF SCOPE AND THE NEEDLE WAS STILL STILL EXPOSED AND WOULD NOT RETRACT BACK INTO THE SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117947 ECHOTIP PROCORE KIT, NEEDLE, BIOPSY FCG COOK, INC. * C826345

    Patients

    Seq Age Sex Outcome Treatment
    1 *