BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOTOME¿ RX 44

    MDR report key: 2792437 · Received October 16, 2012

    Report

    Report Number
    3005099803-2012-04831
    Event Type
    Malfunction
    Date Received
    October 16, 2012
    Date of Event
    September 26, 2012
    Report Date
    September 26, 2012
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) THE REPORTED EVENT OF CUT WIRE BROKE. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE EXPIRATION DATE AND DEVICE MANUFACTURE DATE ARE UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE DEVICE WAS NOT USED PAST THE EXPIRATION DATE. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    A VISUAL AND FUNCTIONAL EXAMINATION OF THE COMPLAINT DEVICE COULD NOT BE PERFORMED SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. DURING MANUFACTURING, THE DEVICES ARE 100% INSPECTED FOR CUT WIRE INTEGRITY. BASED ON SIMILAR COMPLAINT INVESTIGATIONS, THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS OPERATIONAL CONTEXT, LIKELY DUE TO PROCEDURAL FACTORS.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. ASSOCIATED MANUFACTURER REPORT #3005099803-2012-04831 PERTAINS TO THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TWO JAGTOMES WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, FOR EACH OF THESE TWO DEVICES IN TURN, WHEN ATTEMPTING TO PERFORM THE SPHINCTEROTOMY, THE CUT WIRE BROKE. NO PART OF EITHER DEVICE FELL OFF INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER JAGTOME. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "FINE". **ADDITIONAL INFORMATION RECEIVED ** THE TWO COMPLAINT DEVICES (MFR. REPORT # 3005099803-2012-04830 AND MFR. REPORT # 3005099803-2012-04831) WERE AUTOTOME SPHINCTEROTOMES, NOT JAGTOMES AS PREVIOUSLY REPORTED. IN ADDITION, A THIRD AUTOTOME SPHINCTEROTOME WAS USED TO COMPLETE THE PROCEDURE.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. ASSOCIATED MANUFACTURER REPORT #3005099803-2012-04830 PERTAINS TO THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TWO JAGTOMES WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, FOR EACH OF THESE TWO DEVICES IN TURN, WHEN ATTEMPTING TO PERFORM THE SPHINCTEROTOMY, THE CUT WIRE BROKE. NO PART OF EITHER DEVICE FELL OFF INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER JAGTOME. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'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 44 UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - SPENCER M00545170

    Patients

    Seq Age Sex Outcome Treatment
    1