BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOTOME RX SPHINCTEROTOME

    MDR report key: 2131584 · Received June 16, 2011

    Report

    Report Number
    3005099803-2011-02090
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Report Date
    May 27, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    NURSE

    Narratives

    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 LENGTH OF THE EXPOSED CUT WIRE WAS WITHIN SPECIFICATION THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE CUT WIRE WAS BENT. THE BENT CUT WIRE IS LIKELY DUE TO PROCEDURAL FACTORS, THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. (B)(4) FOR THE INVESTIGATION RESULTS OF CUT WIRE BENT. 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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A AUTOTOME RX SPHINCTEROTOME WAS USED DURING A PROCEDURE. ACCORDING TO THE COMPLAINANT, THE DEVICE WAS PLACED DOWN THE SCOPE AND INTO THE PATIENT, IT WAS THEN NOTED THAT THE CUT WIRE WAS BENT AT THE TIP. 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 A AUTOTOME RX SPHINCTEROTOME WAS USED DURING A PROCEDURE. ACCORDING TO THE COMPLAINANT, THE DEVICE WAS PLACED DOWN THE SCOPE AND INTO THE PATIENT, IT WAS THEN NOTED THAT THE CUT WIRE WAS BENT AT THE TIP. 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 UNK24

    Patients

    Seq Age Sex Outcome Treatment
    1