BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOTOME RX SPHINCTEROTOME

    MDR report key: 1895187 · Received November 10, 2010

    Report

    Report Number
    3005099803-2010-04701
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    October 15, 2010
    Report Date
    October 19, 2010
    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 REVEALED THAT THE WORKING LENGTH AND DISTAL TIP WITH EXPOSED CUT WIRE WAS TWISTED AND THE EXPOSED CUT WIRE WAS BENT/ KINKED. A FUNCTIONAL EVALUATION FOUND THAT THE DEVICE WOULD BOW PAST 90 DEGREES WHICH MEETS THE BOWING SPECIFICATION BUT THE BOWING WAS NOT IN PLANE DUE TO THE TWISTED TIP/ BENT WIRE. THE CONDITION OF THE RETURNED UNIT WAS CONSISTENT WITH THE COMPLAINT INCIDENT THAT THE CUTTING WIRE WAS KINKED. DURING MANUFACTURING, TOME DEVICES ARE 100% INSPECTED FOR CUT WIRE AND WORKING LENGTH INTEGRITY SO CUSTOMER USAGE/ PROCEDURAL FACTORS (HANDLE ROTATION) LIKELY TWISTED THE DISTAL TIP AND BENT/ KINKED THE CUT WIRE AND THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMS THAT THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX SPHINCTEROTOME WAS USED DURING A STONE REMOVAL PROCEDURE. ACCORDING TO THE COMPLAINANT, WHEN ATTEMPTING TO BOW THE DEVICE IN THE DUODENUM, IT WAS NOTED THAT THE CUT WIRE WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER AUTOTOME RX SPHINCTEROTOME. 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 GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX SPHINCTEROTOME WAS USED DURING A STONE REMOVAL PROCEDURE. ACCORDING TO THE COMPLAINANT, WHEN ATTEMPTING TO BOW THE DEVICE IN THE DUODENUM, IT WAS NOTED THAT THE CUT WIRE WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER AUTOTOME RX SPHINCTEROTOME. 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 GOOD.

    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 - SPENCER M00545160 13319035

    Patients

    Seq Age Sex Outcome Treatment
    1