BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAGTOME SPHINCTEROTOME

    MDR report key: 1213080 · Received October 23, 2008

    Report

    Report Number
    3005099803-2008-05477
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Date of Event
    September 24, 2008
    Report Date
    September 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (OTHER, WON'T BOW) - THE SUSPECT DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, THE ANALYSIS HAS NOT BEEN COMPLETED, THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION IS CURRENTLY UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2008 THAT A JAGTOME SPHINCTEROTOME DEVICE WAS USED ON THE SAME DATE. ACCORDING TO THE COMPLAINANT, THE JAGTOME DEVICE "WOULD NOT BOW ALL THE WAY UP". REPORTEDLY, THE PROCEDURE WAS COMPLETED WITH ANOTHER JAGTOME SPHINCTEROTOME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAGTOME SPHINCTEROTOME KNS BOSTON SCIENTIFIC CORPORATION M00573040 11974016

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK