BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION OMNI-TOME

    MDR report key: 2960459 · Received January 25, 2013

    Report

    Report Number
    1037905-2013-00043
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    December 12, 2012
    Report Date
    January 15, 2013
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    KNS
    PMA / PMN Number
    K052051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVAL: OUR LAB EVAL OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THAT THE CUTTING WIRE HAS DISCONNECTED FROM THE CATHETER AT THE DISTAL END. THE DISTAL END OF THE CUTTING WIRE HAS PULLED FREE FROM THE CATHETER AT THE DISTAL SKIVE BUT REMAINS ATTACHED AT THE PROXIMAL END. IT WAS NOTED THAT THE SECURING COMPONENT WAS ATTACHED TO THE CUTTING WIRE AND THE TAIL HAD DETACHED AND WAS FULLY ENCASED IN THE DISTAL TIP OF THE CATHETER. NO SECTION OF THE SECURING COMPONENT/CUTTING WIRE IS MISSING. A PRODUCT DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THIS REPORTED OCCURRENCE WAS NOT OBSERVED. 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 CONCLUSIONS: A DEFINITIVE CAUSE FOR THIS OBSERVATION COULD NOT BE DETERMINED BECAUSE THE ACTUAL USE CONDITIONS COULD NOT BE DUPLICATED IN THE LAB SETTING. DUE TO A VARIETY OF CLINICAL CONDITIONS SUCH AS PT ANATOMY OR PROGRESSION OF DISEASE STATE, WE COULD NOT REPRODUCE THE ACTUAL CONDITIONS OF PRODUCT USAGE DURING OUR LAB ANALYSIS. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. A SEPARATED AND/OR BREAKAGE CAN OCCUR IF THE TIP OF THE DEVICE IS OVER FLEXED. THE INSTRUCTIONS FOR USE CAUTION THE USER NOT TO OVER FLEX OR BOW THE TIP BEYOND 90 DEGREES, AS THIS MAY DAMAGE THE SPHINCTEROTOME. CUTTING WIRE SEPARATION AND/OR BREAKAGE CAN ALSO OCCUR IF THE HANDLE IS MANIPULATED WITH THE CATHETER IN THE COILED POSITION OR WITH THE PRECURVED 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 PRECURVED STYLET FROM THE 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." CUTTING WIRE SEPARATION AND/OR BREAKAGE CAN ALSO OCCUR IF THE CUTTING WIRE MAKES CONTACT WITH THE ENDOSCOPE WHEN ELECTROSURGICAL CURRENT IS APPLIED TO PERFORM THE SPHINCTEROTOMY. THE INSTRUCTIONS FOR USE CAUTION THE USER TO ENSURE THE CUTTING WIRE IS COMPLETELY OUT OF THE ENDOSCOPE WHEN APPLYING ELECTROSURGICAL CURRENT. THE INSTRUCTIONS CAUTION THE USER THAT CONTACT OF THE CUTTING WIRE WITH THE ENDOSCOPE COULD RESULT IN BREAKAGE OF THE CUTTING WIRE. IF THE SPHINCTEROTOME IS USED WITH EXCESSIVE ELECTROSURGICAL CURRENT SETTINGS PROVIDED BY THE ELECTROSURGICAL UNIT, THIS CAN CONTRIBUTE TO CUTTING WIRE SEPARATION AND/OR BREAKAGE. THE INSTRUCTIONS FOR USE FOR THIS SPHINCTEROTOME DIRECT THE USER TO VERIFY DESIRED SETTINGS BY FOLLOWING THE ELECTROSURGICAL UNIT MFR¿S INSTRUCTIONS. IF THE ELEVATOR OF THE ENDOSCOPE REMAINS IN THE CLOSED/UP POSITION WHEN RETRACTION OF THE SPHINCTEROTOME IS ATTEMPTED AND ADDITIONAL PRESSURE IS APPLIED, THIS COULD HAVE CONTRIBUTED TO CUTTING WIRE SEPARATION AND/OR BREAKAGE. THE INSTRUCTIONS FOR USE CAUTION THE USER THE ELEVATOR SHOULD REMAIN OPEN/DOWN WHEN ADVANCING OR RETRACTING THE SPHINCTEROTOME. THIS ACTIVITY WILL AID IN DEVICE PRESERVATION. PRIOR TO DISTRIBUTION, ALL FUSION OMNI-TOME SPHINCTEROTOMES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TEST TO ENSURE DEVICE INTEGRITY. THE FUNCTIONAL TEST INCLUDES BOWING THE SPHINCTEROTOME TO ENSURE THE DISTAL END RESPONDS TO HANDLE MANIPULATION. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MFG 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 RESULT AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE.

    Description of Event or Problem · 1

    ON (B)(6) 2012 THE FOLLOWING INFO WAS PROVIDED TO COOK. THE DOCTOR WAS CUTTING THE PAPILLA AND JUST AFTER CUTTING, THE CUTTING WIRE BROKE. THE DOCTOR HAD TO REMOVE THE SPHINCTEROTOME AND USE A NEW ONE. NO SECTION OF THE DEVICE DETACHED INSIDE THE PT. THIS INFO DID NOT REASONABLY SUGGEST A REPORTABLE EVENT HAD OCCURRED. ON (B)(6) 2013 THE PRODUCT WAS RECEIVED FOR EVAL. OUR EVAL OF THE PRODUCT CONFIRMED THAT THE CUTTING WIRE IS INTACT. HOWEVER, THE CUTTING WIRE SECURING COMPONENT HAS SEPARATED FROM THE DISTAL END OF THE CATHETER. THIS HAS BEEN ESTABLISHED AS A REPORTABLE EVENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ANY ADDITIONAL 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
    35960 FUSION OMNI-TOME KNS, ENDOSCOPIC ELECTROSURGICAL UNIT AND ACCESSORIES KNS WILSON-COOK MEDICAL INC W3212394

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS DUODENOSCOPE (UNK TYPE)| COOK METRO WIREGUIDE