BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOTOME RX SPHINCTEROTOME

    MDR report key: 1203280 · Received October 17, 2008

    Report

    Report Number
    3005099803-2008-05362
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    September 16, 2008
    Report Date
    September 18, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER: (TIP DISTORTED).

    Description of Event or Problem · 1

    DURING THE ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN COMMON BILE DUCT, THE AUTOTOME RX SPHINCTEROTOME WAS USED. THE PHYSICIAN REPORTED OF THE TIP BEING DISTORTED. THE CASE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PT'S CONDITION IS REPORTED TO "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOTOME RX SPHINCTEROTOME KNS BOSTON SCIENTIFIC CORPORATION M00545170 11876415

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK