BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D.A.S.H. DOMETIP DOUBLE LUMEN SPHINCTEROTOME

    MDR report key: 2100857 · Received May 13, 2011

    Report

    Report Number
    1037905-2011-00280
    Event Type
    Malfunction
    Date Received
    May 13, 2011
    Report Date
    April 14, 2011
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    KNS
    PMA / PMN Number
    K901443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: A PRODUCT EVAL WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVAL. THE REPORT COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD AND SAMPLE TEST FROM THIS LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. AFTER A REVIEW OF THE ACCOUNT ORDERING AND SHIPPING HISTORY, THE LOT NUMBER INVOLVED COULD NOT BE DETERMINED. CONCLUSIONS: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVAL. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. PRIOR TO DISTRIBUTION, ALL D.A.S.H. DOMETIP DOUBLE LUMEN SPHINCTEROTOMES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTION TEST TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTIONS: NO CORRECTIVE ACTION WARRANTED AT THIS TIME BECAUSE THIS REPORT COULD NOT BE VERIFIED. HOWEVER, THIS TYPE OF OCCURRENCE HAS BEEN BROUGHT TO THE ATTENTION OF THE APPROPRIATE INTERNAL PERSONNEL IN AN EFFORT TO HEIGHTEN AWARENESS. NO FURTHER ACTION WAS TAKEN AT THIS TIME. CUSTOMER QA 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. DOMETIP DOUBLE LUMEN SPHINCTEROTOME. THE DEVICE WAS ADVANCED INTO POSITION AND THE CUTTING WIRE ORIENTATION WAS REPORTED TO BE IN A 2 O'CLOCK POSITION; I.E INCORRECT CUTTING WIRE ORIENTATION. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ANY ADD'L PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 D.A.S.H. DOMETIP DOUBLE LUMEN SPHINCTEROTOME KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS WILSON-COOK MEDICAL INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 ENDOSCOPE (UNK TYPE)