BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAGTOME¿ RX 44

    MDR report key: 2222666 · Received August 25, 2011

    Report

    Report Number
    3005099803-2011-02938
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    August 5, 2011
    Report Date
    August 5, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE WORKING LENGTH WAS TWISTED AND THE CUT WIRE WAS BENT. THE ORIENTATION OF THE DEVICE DID NOT MEET SPECIFICATION. FUNCTIONALLY, WHEN BOWING THE DEVICE IT WOULD NOT BOW IN PLANE DUE TO THE BENT CUT WIRE. DURING MANUFACTURING, TOME DEVICES ARE 100% INSPECTED SO THE BENT CUT WIRE IS LIKELY DUE TO PROCEDURAL FACTORS. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. THE DEVICE HISTORY RECORD REVIEW FOUND THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX SPHINCTEROTOME WAS USED DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN INSERTED THE JAGTOME INTO THE DUODENOSCOPE. IT WAS NOTED ON THE DISPLAY THAT THE ORIENTATION OF THE DISTAL TIP WAS INCORRECT. THE PHYSICIAN ATTEMPTED TO GAIN ACCESS TO THE AMPULLA, AT THIS TIME THE PHYSICIAN ASKED THE NURSE TO BOW THE DEVICE. THE DEVICE BOWED, HOWEVER, IT BOWED OFF IN AN UNINTENDED DIRECTION AND WAS NO LONGER VISIBLE ON THE ENDOSCOPIC MONITOR. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. 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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX SPHINCTEROTOME WAS USED DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN INSERTED THE JAGTOME INTO THE DUODENOSCOPE. IT WAS NOTED ON THE DISPLAY THAT THE ORIENTATION OF THE DISTAL TIP WAS INCORRECT. THE PHYSICIAN ATTEMPTED TO GAIN ACCESS TO THE AMPULLA, AT THIS TIME THE PHYSICIAN ASKED THE NURSE TO BOW THE DEVICE. THE DEVICE BOWED, HOWEVER, IT BOWED OFF IN AN UNINTENDED DIRECTION AND WAS NO LONGER VISIBLE ON THE ENDOSCOPIC MONITOR. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAGTOME¿ RX 44 UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - SPENCER M00573560 13764945

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR