BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION OMNI-TOME

    MDR report key: 11912508 · Received June 1, 2021

    Report

    Report Number
    1037905-2021-00231
    Event Type
    Malfunction
    Date Received
    June 1, 2021
    Date of Event
    March 1, 2021
    Report Date
    June 1, 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

    PMA/510(K) # K172288. INITIAL REPORTER OCCUPATION: UNKNOWN. INVESTIGATION EVALUATION: OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED DETERMINED THE CUTTING WIRE AND CUTTING WIRE SECURING COMPONENT LOCATED NEAR THE DISTAL END OF THE SPHINCTEROTOME HAVE DETACHED. THE CUTTING WIRE AND CUTTING WIRE SECURING COMPONENT WAS RETURNED AND LOCATED WITHIN THE POUCH. THE DETACHED CUTTING WIRE REMAINS ATTACHED TO THE CUTTING WIRE SECURING COMPONENT. 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. FOR FURTHER EVALUATION, THE CATHETER WAS CUT SLIGHTLY TO EXPOSE THE DRIVE WIRE. THE CUTTING WIRE EXHIBITS EVIDENCE OF A CAUTERY APPLICATION (BLACKENING OF THE CUTTING WIRE WAS NOTED) AND AN UNKNOWN LIQUID WAS 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. 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. CUTTING WIRE BREAKAGE CAN 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 WITH THE FOLLOWING COMMENT: ¿WHEN APPLYING CURRENT, ENSURE CUTTING WIRE IS COMPLETELY OUT OF ENDOSCOPE. CONTACT OF CUTTING WIRE WITH ENDOSCOPE MAY CAUSE GROUNDING, WHICH CAN RESULT IN PATIENT INJURY, OPERATOR INJURY, A BROKEN CUTTING WIRE, AND/OR DAMAGE TO ENDOSCOPE.¿ IF THE SPHINCTEROTOME IS USED WITH EXCESSIVE ELECTROSURGICAL CURRENT SETTINGS PROVIDED BY THE ELECTROSURGICAL UNIT, THIS CAN CONTRIBUTE TO CUTTING WIRE BREAKAGE. THE INSTRUCTIONS FOR USE FOR THIS SPHINCTEROTOME DIRECT THE USER WITH THE COMMENT: ¿BEFORE USING THIS DEVICE, FOLLOW RECOMMENDATIONS PROVIDED BY ELECTROSURGICAL UNIT MANUFACTURER TO ENSURE PATIENT SAFETY THROUGH PROPER PLACEMENT AND UTILIZATION OF PATIENT RETURN ELECTRODE. ENSURE A PROPER PATH FROM PATIENT RETURN ELECTRODE TO ELECTROSURGICAL UNIT IS MAINTAINED THROUGHOUT PROCEDURE.¿ PRIOR TO DISTRIBUTION, ALL FUSION OMNI-TOME SPHINCTEROTOMES 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 AND THIS REPRESENTS AN ISOLATED OCCURRENCE. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED REMOTE. 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. THE PHYSICIAN DETECTED THAT THE CUTTING WIRE WAS BROKEN WHILE BEING CHARGED WITH ELECTRICITY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THIS EVENT WAS NOT REPORTABLE AT THIS TIME. THIS DEVICE RETURNED ON 03 MAY 2021 AND IT WAS DETERMINED THE CUTTING WIRE AND CUTTING WIRE SECURING COMPONENT LOCATED NEAR THE DISTAL END OF THE SPHINCTEROTOME DETACHED AND WERE INCLUDED WITH THE RETURNED DEVICE. THE INITIAL REPORTER STATED THAT A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY; HOWEVER IT IS UNKNOWN HOW AND WHEN THE CUTTING WIRE AND CUTTING WIRE SECURING COMPONENT DETACHED . ACCORDING TO THE REPORTER, 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
    810043 FUSION OMNI-TOME KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS COOK ENDOSCOPY W4377886 10827002319032

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR