BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASY CORE BIOPSY SYSTEMS

    MDR report key: 1190809 · Received September 24, 2008

    Report

    Report Number
    2134265-2008-02782
    Event Type
    Malfunction
    Date Received
    September 24, 2008
    Date of Event
    August 25, 2008
    Report Date
    August 26, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FCG
    PMA / PMN Number
    K050120
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE TIP OF THE STYLET BENT. AFTER FIRING THE EASY CORE BIOPSY SYSTEM IN AN UNSPECIFIED LOCATION, THE PHYSICIAN STATED THAT THE "TIP DEFLECT 90 DEGREES." THE DEVICE WAS PULLED OUT OF THE PT. THE PHYSICIAN CONFIRMED THAT THE TIP DID NOT BREAK OFF. THERE WERE NO PT COMPLICATIONS REPORTED. THE PROCEDURE WAS COMPLETED USING ANOTHER MANUFACTURER'S BIOPSY SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASY CORE BIOPSY SYSTEMS FCG KIT, NEEDLE, BIOPSY FCG BOSTON SCIENTIFIC CORPORATION M001434531 11895807

    Patients

    Seq Age Sex Outcome Treatment
    1