BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP ULTRA

    MDR report key: 3140864 · Received May 24, 2013

    Report

    Report Number
    3140864
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 24, 2013
    Manufacturer
    COOK MEDICAL
    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

    THE LUER LOCK SECTION OF THE DEVICE, LOCATED AT THE BASE OF THE BLUE SECTION, WOULD NOT LOCK ON TO THE ACCESSORY CHANNEL PORT OF THE SCOPE. A SECOND NEEDLE WAS USED WITHOUT INCIDENT.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232662 ECHOTIP ULTRA ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY FCG COOK MEDICAL * C855640

    Patients

    Seq Age Sex Outcome Treatment
    1 *