BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D.A.S.H. DOME TIP DOUBLE LUMEN SPHINCTEROTOME

    MDR report key: 2013772 · Received February 4, 2011

    Report

    Report Number
    1037905-2011-00053
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Report Date
    January 6, 2011
    Manufacturer
    WILSON-WILSON MEDICAL INC
    Product Code
    KNS
    PMA / PMN Number
    K901443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: OUR EVALUATION OF THE RETURNED DEVICE WAS UNABLE TO CONFIRM THE REPORT OF INCORRECT CUTTING WIRE ORIENTATION. DURING OUR LABORATORY ANALYSIS, THE SPHINCTEROTOME WAS ADVANCED THROUGH A DUODENOSCOPE THAT IS PLACED IN A SIMULATED BILIARY POSITION. THE DUODENOSCOPE HAS AN ACCESSORY CHANNEL THAT IS 4.2MM IN DIAMETER (MODEL NUMBER OLYMPUS TJF-140R). THE CATHETER EXITED THE ENDOSCOPE WITH THE CUTTING WIRE FACING 1:00. (APPROPRIATE ORIENTATION IS APPROX 11:00 -1:00 O'CLOCK.) A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS. A SAMPLE FROM OUR FINISHED GOODS, SHELF STOCK WAS ALSO EVALUATED. THE SPHINCTEROTOME WAS ADVANCED THROUGH A DUODENOSCOPE THAT IS PLACED IN A SIMULATED BILIARY POSITION. THE CATHETER EXITED THE ENDOSCOPE WITH THE CUTTING WIRE FACING. 12:00. (APPROPRIATE ORIENTATION IS APPROX 11:00 - 1:00 O'CLOCK). AFTER A REVIEW OF THE DEVICE HISTORY RECORD FROM THE LOT NUMBER SAID TO BE INVOLVED, WE CAN REPORT NO DISCREPANCIES OR ANOMALIES WERE OBSERVED. CONCLUSIONS: A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED BECAUSE THE PRODUCT SAID TO BE INVOLVED FUNCTIONED AS INTENDED. A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED OBSERVATION WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS OF THE RETURNED PRODUCT. PRIOR TO DISTRIBUTION, ALL D.A.S.H. DOMETIP DOUBLE LUMEN SPHINCTEROTOMES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TEST TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: NO CORRECTIVE ACTION WARRANTED AT THIS TIME BECAUSE THE REPORT WAS UNABLE TO BE VERIFIED. CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP). THE PHYSICIAN USED A COOK D.A.S.H. DOME TIP DOUBLE LUMEN SPHINCTEROTOME. THE SPHINCTEROTOME WAS ADVANCED THROUGH THE ACCESSORY CHANNEL OF THE ENDOSCOPE. WHEN THE CUTTING WIRE EXITED THE DISTAL END OF THE ENDOSCOPE, THE POSITION OF THE CUTTING WIRE WAS REPORTED TO BE IN A 2 O'CLOCK POSITION (I.E. INCORRECT CUTTING WIRE ORIENTATION). THE SPHINCTEROTOME WAS REMOVED AND ANOTHER PRODUCT WAS USED TO COMPLETE THE PROCEDURE. A FOREIGN OBJECT DID NOT HAVE TO BE RETRIEVED FROM THE PT. NO ADD'L MEDICAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE. THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 D.A.S.H. DOME TIP DOUBLE LUMEN SPHINCTEROTOME KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WIHTOUT ACCESSORIES) KNS WILSON-WILSON MEDICAL INC W2940439

    Patients

    Seq Age Sex Outcome Treatment
    1 ENDOSCOPE (UNK TYPE)