BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOTOME SPHINCTEROTOME

    MDR report key: 879494 · Received July 12, 2007

    Report

    Report Number
    6000048-2007-00232
    Event Type
    Malfunction
    Date Received
    July 12, 2007
    Date of Event
    June 13, 2007
    Report Date
    June 14, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S COMPLAINT HAS BEEN CONFIRMED. VISUAL EXAM OF THE RETURNED DEVICE CONFIRMED THAT THE CUTTING WIRE WAS BROKEN; THE BROKEN ENDS APPEARED BLACKENED AND MELTED. SEE FIGURES 1 THROUGH 3. A REVIEW OF THE CUSTOMER SHIPMENT HISTORY IDENTIFIED THREE POSSIBLE LOTS, WHICH THE SUSPECT DEVICE MAY HAVE ORIGINATED (9115994, 9050616, AND 9102226). THE DEVICE HISTORY RECORDS FOR THESE LOTS WERE REVIEWED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE IDENTIFIED NO ADDITIONAL COMPLAINTS REPORTED FOR THESE LOTS. THE MAY 2007 15-MONTH AUTOTOME SPHINCTEROTOME PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED: NO ADVERSE TREND WAS NOTED AND NO DATA POINT EXCEEDED THE COMPLAINT ALERT LIMIT. TWO MOST LIKELY CAUSES FOR BROKEN CUTTING WIRES EXHIBITING BURNT, MELTED ENDS INCLUDE: IMPROPER TOME POSITIONING, ALLOWING THE CUTTING WIRE TO CONTACT THE SCOPE, RESULTING IN A SHORT CIRCUIT, AND EXCESSIVE POWER APPLIED TO THE CUTTING WIRE DUE TO IMPROPER GENERATOR SETTINGS. BOTH OF THESE SCENARIOS WOULD BE ATTRIBUTED TO USER-INTERFACE.

    Description of Event or Problem · 1

    NOTE: THE DATE OF EVENT IS UNKNOWN. IN 2007, IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING AN ENDOSCOPIC SPHINCTEROTOMY (PATIENT AGE AND GENDER UNKNOWN) USING AN AUTOTOME SPHINCTEROTOME, THE "CUTTING WIRE WAS BROKEN". THE PROCEDURE WAS COMPLETED USING AN UNKNOWN DEVICE (MANUFACTURER AND PRODUCT). THE PATIENT'S CONDITION WAS REPORTED AS "OK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOTOME SPHINCTEROTOME KNS BOSTON SCIENTIFIC M00545180 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR