BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 10461107 · Received August 27, 2020

    Report

    Report Number
    1037905-2020-00340
    Event Type
    Malfunction
    Date Received
    August 27, 2020
    Date of Event
    July 31, 2020
    Report Date
    September 16, 2020
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    KNS
    UDI-DI
    10827002252278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INFORMATION REGARDING PMA/510(K) # : K172665. INITIAL REPORTER OCCUPATION: UNKNOWN. INVESTIGATION EVALUATION: OUR EVALUATION OF THE RETURNED DEVICE COULD NOT CONFIRM THE REPORT OF INCORRECT CUTTING WIRE ORIENTATION. THE DEVICE WAS RETURNED WITH THE PRE-LOADED WIRE GUIDE. 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 4.2 MM IN DIAMETER (MODEL NUMBER OLYMPUS TJF-160V). THE CATHETER EXITED THE ENDOSCOPE WITH THE CUTTING WIRE FACING 1 O¿CLOCK. THE DEVICE WAS THEN BOWED AND THE CUTTING WIRE WAS FACING 12 O'CLOCK (APPROPRIATE ORIENTATION IS APPROXIMATELY 11:00 - 1:00 O'CLOCK). THE SPHINCTEROTOME CATHETER WAS SUBJECTED TO A CLOSE VISUAL EXAMINATION AND TWISTING OF THE TUBING WAS NOT OBSERVED AT THE DISTAL END, BUT THE CUTTING WIRE APPEARED SLIGHTLY BENT. LIQUID WAS OBSERVED INSIDE OF THE CATHETER AND, AN UNKNOWN RED-COLORED SUBSTANCE ON THE DISTAL TIP OF THE SPHINCTEROTOME WAS ALSO OBSERVED. A VISUAL EXAMINATION OF THE PRE-LOADED WIRE GUIDE WAS PERFORMED AND A KINK/BEND WAS NOT OBSERVED. A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS OF THE RETURNED PRODUCT. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. INVESTIGATION CONCLUSION: 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. FACTORS THAT CAN CONTRIBUTE TO IMPROPER CUTTING WIRE ORIENTATION INCLUDE MANIPULATING THE HANDLE WITH THE CATHETER IN A COILED POSITION OR WITH THE PRECURVED STYLET INSIDE THE CANNULATING TIP. THE INSTRUCTIONS FOR USE ADVISE THE USER: "UPON REMOVING DEVICE FROM PACKAGE, UNCOIL AND STRAIGHTEN SPHINCTEROTOME. CAREFULLY REMOVE PRECURVED STYLET FROM CANNULATING TIP." THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING COMMENT: "NOTE: DO NOT EXERCISE HANDLE WHILE DEVICE IS COILED OR PRECURVED 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. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE.

    Description of Event or Problem · 0

    DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) THE PHYSICIAN USED A COOK D.A.S.H. DOMETIP DOUBLE LUMEN SPHINCTEROTOME. THE SPHINCTEROTOME WAS TESTED. IT WAS INSERTED INTO THE WORKING CHANNEL OF THE DUODENOSCOPE. THE SPHINCTEROTOME EXITED IN REVERSE ORIENTATION TO THE PAPILLA [INCORRECT CUTTING WIRE ORIENTATION]. 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.

    Additional Manufacturer Narrative · 1

    INFORMATION REGARDING PMA/510(K) # : K172665. INITIAL REPORTER OCCUPATION: UNKNOWN. THE INVESTIGATION IS ON-GOING. A FOLLOW-UP EMDR WILL BE PROVIDED WITH THE PRODUCT EVALUATION INFORMATION.

    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 SPHINCTEROTOME WAS TESTED. IT WAS INSERTED INTO THE WORKING CHANNEL OF THE DUODENOSCOPE. THE SPHINCTEROTOME EXITED IN REVERSE ORIENTATION TO THE PAPILLA [INCORRECT CUTTING WIRE ORIENTATION]. 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
    926821 D.A.S.H. DOMETIP DOUBLE LUMEN SPHINCTEROTOME KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS COOK ENDOSCOPY W4335352 10827002252278

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR ERBE ELECTROSURGICAL GENERATOR, MODEL UNKNOWN.| PENTAX ED-3490TK, DUODENOSCOPE.| ERBE ELECTROSURGICAL GENERATOR, MODEL UNKNOWN.| PENTAX ED-3490TK, DUODENOSCOPE.