BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION OMNI-TOME

    MDR report key: 12021095 · Received June 17, 2021

    Report

    Report Number
    1037905-2021-00258
    Event Type
    Malfunction
    Date Received
    June 17, 2021
    Date of Event
    May 13, 2021
    Report Date
    June 17, 2021
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    KNS
    UDI-DI
    10827002319032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONTINUED: SECTION G. PMA/510(K) # K172288. INVESTIGATION EVALUATION: THE PRODUCT SAID TO BE INVOLVED WAS RETURNED IN A BIO BAG. PROVIDED WITH THE RETURN WAS AN OPEN POUCH FROM THE LOT NUMBER PROVIDED IN THE REPORT. THE LABEL MATCHES THE PRODUCT RETURNED. PICTURES WERE PROVIDED AND REVIEWED. THE PICTURES PROVIDED SHOW THE DISTAL END OF THE DEVICE, AND THE CUTTING WIRE HAS SEPARATED FROM THE CATHETER AT THE DISTAL END. OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE CUTTING WIRE SECURING COMPONENT LOCATED NEAR THE DISTAL END OF THE SPHINCTEROTOME HAS DISCONNECTED FROM THE CATHETER. THE CUTTING WIRE IS INTACT AND REMAINS SECURELY ATTACHED TO THE SPHINCTEROTOME AT THE PROXIMAL END. HOWEVER, DUE TO THE CATHETER AND SECURING COMPONENT DISCONNECTION, THE DISTAL END OF THE CUTTING WIRE IS NO LONGER CONNECTED TO THE SPHINCTEROTOME CATHETER AT THE DISTAL END. THE SECURING COMPONENT HAS A LONGER SECTION MEASURING 3.0 MM AND A SHORTER SECTION MEASURING 2.0 MM, THEREFORE NO PART OF THE DEVICE IS MISSING. AN UNKNOWN YELLOW SUBSTANCE WAS OBSERVED ON AND WITHIN THE CATHETER NEAR THE DISTAL END. A BLACK SUBSTANCE WAS ALSO OBSERVED NEAR THE DISTAL END. LIQUID WAS ALSO OBSERVED IN THE CATHETER. 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 CONCLUSION: A DEFINITIVE CAUSE FOR THIS OBSERVATION COULD NOT BE DETERMINED BECAUSE THE ACTUAL USE CONDITIONS COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. IN ADDITION, 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. 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." 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 CAN CONTRIBUTE TO SEPARATION OF THE CATHETER AND CUTTING WIRE SECURING COMPONENT. THE INSTRUCTIONS FOR USE CAUTION THE USER: "ELEVATOR SHOULD REMAIN OPEN/DOWN WHEN ADVANCING OR RETRACTING SPHINCTEROTOME." THIS ACTIVITY WILL AID IN DEVICE PRESERVATION. 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 OMNI-TOMES 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 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 · 1

    DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK FUSION OMNI-TOME AND STATED THAT DURING THE PROCEDURE THE CUTTING WIRE BROKE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. A PHOTO OF THE DEVICE WAS PROVIDED ON 26-MAY-2021 WHICH SHOWS THAT THE CUTTING WIRE ANCHOR DISCONNECTED AT THE PATIENT END OF DEVICE. [SUBJECT OF REPORT]. OUR ATTEMPTS TO COLLECT SPECIFIC PATIENT OUTCOME INFORMATION WERE UNSUCCESSFUL. BECAUSE THE COMPLAINANT STATED THAT THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT, WE CAN CONCLUDE THAT THIS INFORMATION DOES NOT REASONABLY SUGGEST THE PATIENT WAS ADVERSELY IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911955 FUSION OMNI-TOME KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS COOK ENDOSCOPY W4454708 10827002319032

    Patients

    Seq Age Sex Outcome Treatment
    1