BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1882689 · Received October 20, 2010

    Report

    Report Number
    1037905-2010-00497
    Event Type
    Malfunction
    Date Received
    October 20, 2010
    Report Date
    September 20, 2010
    Manufacturer
    COOK ENDOSCOPY
    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

    EVAL: WE COULD NOT CONFIRM THE REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED TO COOK ENDOSCOPY FOR EVAL. WE COULD NOT CONDUCT A REVIEW OF THE DEVICE HISTORY RECORD OR CONDUCT SAMPLE TEST FROM THIS LOT BECAUSE THE LOT NUMBER WAS NOT PROVIDED. AFTER A REVIEW OF THE ACCOUNT ORDERING AND SHIPPING HISTORY, THE LOT NUMBER 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. IMPROPER CUTTING WIRE ORIENTATION CAN OCCUR IF THE DISTAL END OF THE CATHETER IS SHAPED MANUALLY. THE SPHINCTEROTOME CATHETER IS PRE-CURVED AND IS PROVIDED WITH A PRE-CURVED STYLET IN THE DISTAL TIP OF THE CATHETER. THIS OBVIATES THE NEED FOR MANUAL FORMATION. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING COMMENT: "NOTE: DO NOT APPLY MANUAL PRESSURE TO TIP OR CUTTING WIRE OF THE SPHINCTEROTOME TO INFLUENCE ORIENTATION, AS THIS MAY RESULT IN DAMAGE TO DEVICE." OTHER FACTORS THAT CAN CONTRIBUTE TO IMPROPER CUTTING WIRE ORIENTATION INCLUDE MANIPULATING THE HANDLE WITH THE CATHETER IN A COILED POSITION OR WITH THE PRE-CURVED STYLET INSIDE THE CANNULATING TIP. THE INSTRUCTIONS FOR USE ADVISE THE USER TO UNCOIL AND STRAIGHTEN THE SPHINCTEROTOME UPON REMOVING THE DEVICE FROM THE PACKAGING. THE USER IS THEN INSTRUCTED TO CAREFULLY REMOVE THE PRE-CURVED STYLET FROM THE CANNULATING TIP. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING COMMENT: "NOTE: DO NOT EXERCISE HANDLE WHILE DEVICE IS COILED OR PRE-CURVED STYLET IS IN PLACE, AS THIS MAY CAUSE DAMAGE TO SPHINCTEROTOME AND RENDER IT INOPERABLE." 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. CORRECTIVE ACTION: NO CORRECTIVE ACTION WARRANTED AT THIS TIME BECAUSE THE REPORT WAS UNABLE TO BE VERIFIED. THE APPROPRIATE PERSONNEL HAVE BEEN MADE AWARE OF THIS TYPE OF REPORT IN AN EFFORT TO HEIGHTEN AWARENESS. 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 ENDOSCOPY D.A.S.H. DOMETIP DOUBLE LUMEN SPHINCTEROTOME. THE SPHINCTEROTOME WAS ADVANCED THROUGH THE ACCESSORY CHANNEL OF THE ENDOSCOPE. WHEN THE TIP OF THE SPHINCTEROTOME EXITED THE ENDOSCOPE, THE CUTTING WIRE ORIENTATION WAS REPORTED TO BE BETWEEN 1:00 AND 2:00 (CORRECT ORIENTATION IS APPROX 11:00 TO 1:00). THE HANDLE OF THE SPHINCTEROTOME WAS ROTATED IN AN ATTEMPT TO INFLUENCE ORIENTATION OF THE CUTTING WIRE BUT THIS WAS UNSUCCESSFUL. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. 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 RPTR, 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 COOK ENDOSCOPY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS ENDOSCOPE (UNKNOWN MODEL NUMBER)