BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JAGTOME RX 44

    MDR report key: 3032667 · Received March 29, 2013

    Report

    Report Number
    MW5029565
    Event Type
    Injury
    Date Received
    March 29, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 19, 2013
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    KNS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE DOING AN ERCP, JAGTOME PLACED THROUGH SCOPE FOR SPHINCTEROTOMY. WHEN DEVICE WAS FLEXED THE WIRE BROKE. THE DEVICE WAS REMOVED THROUGH SCOPE. NO APPARENT INJURY TO PT OR DAMAGE TO SCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131206 JAGTOME RX 44 JAGTOME KNS BOSTON SCIENTIFIC RX 44 15766091

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention