BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 1598512 · Received February 2, 2010

    Report

    Report Number
    MW5014650
    Event Type
    Malfunction
    Date Received
    February 2, 2010
    Date of Event
    January 28, 2010
    Report Date
    February 2, 2010
    Product Code
    KNS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON SIX SEPARATE OCCASIONS IN ENDOSCOPY, SHEARED PIECES OF THE JAGWIRE WERE NOTED IN THE PORT OF THE ULTRATOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC ULTRATOME KNS SEE EVENT DESCRIPTION 13025555
    2 BOSTON SCIENTIFIC JAGWIRE EZB SEE EVENT DESCRIPTION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1