BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOTOME RX SPHINCTEROTOME

    MDR report key: 1328401 · Received March 3, 2009

    Report

    Report Number
    3005099803-2008-01396
    Event Type
    Malfunction
    Date Received
    March 3, 2009
    Date of Event
    September 26, 2005
    Report Date
    September 28, 2005
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION-SPENCER
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE MANUFACTURE AND EXPIRATION DATE ARE UNKNOWN. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE IS NOT AVAILABLE FOR RETURN. A DEVICE EVALUATION CANNOT BE PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A AUTOMTOME RX SPHINCTEROTOME WAS USED DURI NG A PROCEDURE PERFORMED IN 2005 (PATIENT GENDER, AGE, AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, THE TOME WOULD NOT BOW. A SECOND DEVICE WAS USED AND THE PROCEDURE WAS SUCCESSFUL. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOTOME RX SPHINCTEROTOME UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC CORPORATION-SPENCER M00545170

    Patients

    Seq Age Sex Outcome Treatment
    1