BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP ULTRA

    MDR report key: 3042031 · Received April 5, 2013

    Report

    Report Number
    3042031
    Event Type
    Malfunction
    Date Received
    April 5, 2013
    Date of Event
    March 25, 2013
    Report Date
    April 5, 2013
    Manufacturer
    COOK MEDICAL, ENDOSCOPY
    Product Code
    FCG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    EUS (ENDOSCOPIC ULTRASOUND) NEEDLE DID NOT DEPLOY.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?GASTRO.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141120 ECHOTIP ULTRA KIT, NEEDLE, BIOPSY FCG COOK MEDICAL, ENDOSCOPY * C853365

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR