BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOTOME RX SPHINCTEROTOME

    MDR report key: 1230423 · Received November 7, 2008

    Report

    Report Number
    3005099803-2008-06161
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 10, 2008
    Report Date
    October 10, 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

    (B)(4). ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. (B)(4).

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO THE THIRD OF THREE REPORTED MALFUNCTIONS WHICH OCCURRED DURING THE PROCEDURE. REFER TO MFR REPORTS #3005099803-2008-06159 AND #3005099803-2008-06160 FOR DETAILS REGARDING THE FIRST AND SECOND DEVICES. ACCORDING TO THE COMPLAINT, THE PHYSICIAN EXPERIENCED A BOWING PROBLEM WITH THIS SECOND AUTOTOME RX SPHINCTEROTOME DEVICE AND WAS ABLE TO PERFORM AN "ADEQUATE SPHINCTEROTOMY". THERE WAS NO PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PT'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 AUTOTOME RX SPHINCTEROTOME KNS BOSTON SCIENTIFIC CORPORATION M00545150 11945013

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK