BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION OMNI-TOME

    MDR report key: 12080464 · Received June 28, 2021

    Report

    Report Number
    1037905-2021-00279
    Event Type
    Malfunction
    Date Received
    June 28, 2021
    Date of Event
    April 20, 2021
    Report Date
    June 28, 2021
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    KNS
    UDI-DI
    10827002319032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER OCCUPATION: SECRETARY. PMA/510(K): K172288. INVESTIGATION EVALUATION: DEVICE 1: 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. THE CUTTING WIRE ALSO EXHIBITS SLIGHT EVIDENCE OF A CAUTERY APPLICATION (BLACKENING OF THE CUTTING WIRE WAS NOTED) AND THERE IS AN UNKNOWN RED SUBSTANCE IN THE DISTAL TIP OF THE DEVICE. A PRODUCT DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THIS REPORTED OCCURRENCE WAS NOT OBSERVED. DEVICE 2: 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. THE CUTTING WIRE ALSO EXHIBITS SLIGHT EVIDENCE OF A CAUTERY APPLICATION (BLACKENING OF THE CUTTING WIRE WAS NOTED). 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. 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 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. 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), THE PHYSICIAN USED TWO (2) FUSION OMNI-TOMES. THERE WAS A LACK OF TENSION IN THE CUTTING WIRE DURING USE THEN BREAKAGE OF THE CUTTING WIRE. THIS INFORMATION WAS NOT REPORTABLE. NEW INFORMATION RECEIVED FROM QUALITY ENGINEERING ON 08-JUNE-2021 STATES THAT THE ANCHORS HAVE SEPARATED FROM THE TIP. ADDITIONAL INFORMATION RECEIVED ON 08-JUNE-2021 STATES THAT THE DISTAL TIP WAS NOT FORMED MANUALLY. WE DIDN'T TURN THE HANDLE. THE POSITION OF THE DUODENOSCOPE WAS IN D2 IN FRONT OF THE PAPILLA. WE HAVE A DUODENOSCOPE OLYMPUS TJF-Q190V AND A GENERATOR ERBE VIO 3 WITH ENDOSCOPE I 2. THE ACTIVE CORD WORKED WELL WITH OTHER PRODUCTS AND THE WIRE GUIDE WAS IN THE SPHINCTEROTOME DURING THE CUT OF THE PAPILLA. BUT THEY NOTICED DIFFICULTIES TO BEND THE CUTTING WIRE OF THE CATHETER AND IT BROKE. THE NURSE DIDN'T REMEMBER WHERE EXACTLY ON THE SPHINCTEROTOME. SHE SAID THAT SHE SENT THE DEVICES TO PURCHASER DEPARTMENT. NOTHING CAME OFF THE CATHETER NEITHER INTO THE COMMON BILE DUCT (CBD). THEY USED A NEW SPHINCTEROTOME TO FINISH THE PROCEDURE. 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
    975913 FUSION OMNI-TOME KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS COOK ENDOSCOPY W4363586 10827002319032

    Patients

    Seq Age Sex Outcome Treatment
    1