BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOTOME RX SPHINCTEROTOME

    MDR report key: 1140584 · Received August 28, 2008

    Report

    Report Number
    3005099803-2008-04187
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    August 1, 2008
    Report Date
    August 1, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER: ORIENTATION. THE SUSPECT DEVICE HAS BEEN DISPOSED. A DEVICE EVALUATION WILL NOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC THAT DURING THE ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP), THE SPHINCTEROTOME CAME OUT OF THE SCOPE ORIENTATED TO THE RIGHT, WHEN THE PHYSICIAN TRIED TO DO THE SPHINCTEROTOMY THE CUT WIRE WOULD BARELY BOW AT ALL AND THE CUT ORIENTATION WAS CUTTING TO THE RIGHT. THE CASE WAS COMPLETED WITH THIS DEVICE. THE PATIENT WAS REPORTED TO BE "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOTOME RX SPHINCTEROTOME KNS BOSTON SCIENTIFIC CORPORATION M00545170 11767897

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK