BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION PRE-LOADED WITH ACROBAT WIRE GUIDE

    MDR report key: 12606944 · Received October 11, 2021

    Report

    Report Number
    1037905-2021-00568
    Event Type
    Malfunction
    Date Received
    October 11, 2021
    Date of Event
    September 14, 2021
    Report Date
    October 11, 2021
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    KNS
    UDI-DI
    10827002346939
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K172288. INVESTIGATION EVALUATION: OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED DETERMINED THE CUTTING WIRE SECURING COMPONENT LOCATED NEAR THE DISTAL END OF THE SPHINCTEROTOME HAS DISCONNECTED FROM THE CATHETER. HOWEVER, THE CUTTING WIRE IS INTACT AND REMAINS SECURELY ATTACHED TO THE SPHINCTEROTOME AT THE PROXIMAL END. A SECTION OF THE CUTTING WIRE SECURING COMPONENT HAS BROKEN AND DETACHED FROM THE DEVICE. THE BROKEN SECTION IS ESTIMATED TO BE 3.0MM IN LENGTH AND 0.5MM IN DIAMETER. THE BROKEN SECTION WAS NOT INCLUDED IN THE RETURN. THERE WAS GREEN AND BROWN LIQUID OBSERVED IN THE CATHETER AND THE WIRE GUIDE LUMEN WAS FULLY UTILIZED. THE CATHETER IS ALSO BENT FROM APPROXIMATELY 17.0CM TO 23.0CM FROM THE DISTAL END. A PRODUCT DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THIS REPORTED OCCURRENCE WAS NOT OBSERVED. THE DEVICE HISTORY RECORD WAS REVIEWED. THE DEVICE HISTORY RECORD CONTAINS A NONCONFORMANCE THAT COULD POTENTIALLY BE RELATED TO THE CUTTING WIRE SECURING COMPONENT (ANCHOR) SEPARATING FROM THE CATHETER. THE DEVICE GOES THROUGH VARIOUS INSPECTIONS PRIOR TO LEAVING THE FACILITY. THESE INSPECTIONS WOULD HAVE REMOVED ANY NONCONFORMING DEVICES PRIOR TO DISTRIBUTION. INVESTIGATION CONCLUSION: A DEFINITIVE CAUSE FOR THIS OBSERVATION COULD NOT BE DETERMINED BECAUSE THE ACTUAL USE CONDITIONS COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. DUE TO A VARIETY OF CLINICAL CONDITIONS SUCH AS PATIENT ANATOMY, ENDOSCOPE POSITION OR PROGRESSION OF DISEASE STATE, WE COULD NOT REPRODUCE THE ACTUAL CONDITIONS OF PRODUCT USAGE DURING OUR LABORATORY ANALYSIS. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. SEPARATION OF THE CUTTING WIRE SECURING COMPONENT AND THE CATHETER CAN OCCUR IF THE TIP OF THE SPHINCTEROTOME IS OVER FLEXED. THE INSTRUCTIONS FOR USE CAUTION THE USER: "DO NOT OVER FLEX OR BOW TIP BEYOND 90 DEGREES, AS THIS MAY DAMAGE OR CAUSE CUTTING WIRE TO BREAK." OTHER FACTORS THAT CAN CONTRIBUTE TO SEPARATION OF THE CUTTING WIRE SECURING COMPONENT AND THE CATHETER 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 FUSION® PRE-LOADED WITH ACROBAT WIRE GUIDES ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. THE VISUAL INSPECTION ENSURES THE PRODUCT IS FREE OF KINKS. 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) PROCEDURE, THE PHYSICIAN USED A COOK FUSION® PRE-LOADED WITH ACROBAT WIRE GUIDE. IT WAS INITIALLY REPORTED THAT THE SPHINCTEROTOME WAS USED TO CANNULATE AND WAS WITHDRAWN FROM THE SCOPE. THE PHYSICIAN DECIDED TO GO BACK-DOWN WITH THE SPHINCTEROTOME AND THE CUTTING WIRE WAS BROKEN. AT THIS TIME, THE PHYSICIAN ELECTED TO PLACE A PLASTIC STENT TO COMPLETE THE INTENDED PROCEDURE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. OUR EVALUATION OF THE RETURNED DEVICE DETERMINED THAT THE CUTTING WIRE SECURING COMPONENTS (ANCHORS) HAS SEPARATED FROM THE CATHETER (W/ DETACHMENT) RESULTING IN TIP WILL NOT BOW. [SUBJECT OF REPORT] 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
    1502895 FUSION PRE-LOADED WITH ACROBAT WIRE GUIDE KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS COOK ENDOSCOPY G34693 W4466024 10827002346939

    Patients

    Seq Age Sex Outcome Treatment
    1 CONMED ELECTROSURGICAL GENERATOR| COOK ACRO-35-260 WIRE GUIDE| OLYMPUS ENDOSCOPE, UNKNOWN MODEL