BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOTOME¿ RX 44

    MDR report key: 2896802 · Received January 4, 2013

    Report

    Report Number
    3005099803-2012-06209
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 13, 2012
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THAT THE DEVICE DID NOT PRESENT FAILURES. FUNCTIONAL EVALUATION FOUND THAT THE DEVICE WOULD BOW ACCORDING TO SPECIFICATION. THE RESISTANCE OF THE WIRE WAS FOUND TO MEET SPECIFICATION. THE LENGTH OF THE CUTTING WIRE WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATIONS. THE DEVICE FUNCTIONED AS INTENDED WITH RESPECT TO ELECTRICAL FUNCTIONALITY. THE INVESTIGATION WAS UNABLE TO CONFIRM THE REPORTED COMPLAINT. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED LOT. THE DEVICE HISTORY RECORD REVIEW FOUND THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR. REPORT # 3005099803-2012-06209 AND MFR. REPORT # 3005099803-2012-06210). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO AUTOTOMES WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE WAS UNABLE TO CUT THE PAPILLA. A SECOND DEVICE WAS USED, BUT THIS DEVICE WAS ALSO UNABLE TO CUT THE PAPILLA. THE PROCEDURE WAS COMPLETED WITH A THIRD AUTOTOME. 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 STABLE.

    Description of Event or Problem · 1

    NOTE: THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR. REPORT # 3005099803-2012-06209 AND MFR. REPORT # 3005099803-2012-06210). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO AUTOTOMES WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE WAS UNABLE TO CUT THE PAPILLA. A SECOND DEVICE WAS USED, BUT THIS DEVICE WAS ALSO UNABLE TO CUT THE PAPILLA. THE PROCEDURE WAS COMPLETED WITH A THIRD AUTOTOME. 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 STABLE. **ADDITIONAL INFORMATION (B)(6) 2013** A NON-BSC ACTIVE CORD WAS USED. THERE WAS NO VISIBLE DAMAGE TO EITHER AUTOTOME.

    Description of Event or Problem · 1

    NOTE: THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR. REPORT # 3005099803-2012-06209 AND MFR. REPORT # 3005099803-2012-06210). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO AUTOTOMES WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE WAS UNABLE TO CUT THE PAPILLA. A SECOND DEVICE WAS USED, BUT THIS DEVICE WAS ALSO UNABLE TO CUT THE PAPILLA. THE PROCEDURE WAS COMPLETED WITH A THIRD AUTOTOME. 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 STABLE. (B)(4) 2013 - A NON-BSC ACTIVE CORD WAS USED. THERE WAS NO VISIBLE DAMAGE TO EITHER AUTOTOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4386 AUTOTOME¿ RX 44 UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - SPENCER M00545180 15061792

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR