BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1994375 · Received January 14, 2011

    Report

    Report Number
    1037905-2011-00028
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    November 26, 2010
    Report Date
    December 15, 2010
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    KNS
    PMA / PMN Number
    K901443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COOK RECEIVED ADDITIONAL INFORMATION REGARDING PATIENT IMPACT AND PRODUCT USAGE. THE INFORMATION REGARDING PRODUCT USAGE ALSO CHANGED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    ON 11/29/2010 THE FOLLOWING INFORMATION WAS PROVIDED TO COOK ENDOSCOPY DURING AN ENDOSCOPIC PROCEDURE THE PHYSICIAN USED A COOK ENDOSCOPY D A S H DOMETIP DOUBLE LUMEN SPHINCTEROTOME. THE USER REPORTED THE COAXIAL COVE DOES NOT WORK SEVERAL ATTEMPTS WERE MADE IN AN EFFORT TO COLLECT CLARIFICATION OF THE TERM "COAXIAL COVE" AS IT RELATES TO OUR DEVICE, BUT THE INFORMATION WAS NOT PROVIDED. ON 12/15/2010, THE DEVICE WAS RETURNED FOR EVALUATION. UPON EVALUATION, WE CONFIRMED THE CUTTING WIRE ORIENTATION OF THE DEVICE WAS INCORRECT. OUR EVALUATION OF THE RETURNED PRODUCT CONFIRMED NO PORTION OF THE PRODUCT IS MISSING. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362648 D.A.S.H. DOMETIP DOUBLE LUMEN SPHINCTEROTOME KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS WILSON-COOK MEDICAL INC W2868417

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ENDOSCOPE (UNKNOWN TYPE).| ERBE ELECTROSURGICAL UNIT (UNKNOWN MODEL NUMBER).