BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME

    MDR report key: 13996955 · Received April 4, 2022

    Report

    Report Number
    1037905-2022-00153
    Event Type
    Malfunction
    Date Received
    April 4, 2022
    Date of Event
    February 14, 2022
    Report Date
    May 25, 2022
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    KNS
    UDI-DI
    00827002558144
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) #K172288. INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. THE REPORT COULD NOT BE CONFIRMED. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. THE DEVICE HISTORY RECORD CONTAINS A NONCONFORMANCE THAT COULD POTENTIALLY BE RELATED TO THE CUTTING WIRE SECURING COMPONENT SEPARATING FROM CATHETER. THE DEVICE GOES THROUGH VARIOUS INSPECTIONS PRIOR TO LEAVING THE FACILITY. THESE INSPECTIONS WOULD HAVE REMOVED ANY NONCONFORMING DEVICES PRIOR TO DISTRIBUTION. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. INVESTIGATION CONCLUSION: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. 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 PRE-LOADED 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 MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: 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.

    Additional Manufacturer Narrative · 0

    AN EMDR REPORT WAS INITIALLY SENT ON 04 APRIL 2022, BASED ON THE INFORMATION THAT THE CUTTING WIRE DETACHED AT THE PATIENT END OF THE SPHINCTEROTOME. THE DEVICE WAS RECEIVED FOR EVALUATION ON 27 APRIL 2022. OUR EVALUATION OF THE RETURNED DEVICE WAS UNABLE TO CONFIRM THE REPORT AND DETERMINED THAT THE CUTTING WIRE SECURING COMPONENT (ANCHOR) MOVED PROXIMAL TO INTENDED LOCATION WITHIN CATHETER. THIS MALFUNCTION HAS NOT HISTORICALLY CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY. THEREFORE, THIS NO LONGER MEETS FDA REPORTING REQUIREMENTS AND THIS FOLLOW UP EMDR IS BEING SENT TO CANCEL THE INITIAL EMDR.

    Description of Event or Problem · 0

    DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED TWO (2) COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOMES. IT WAS INITIALLY REPORTED THAT THE CUTTING WIRES BECAME "DAMAGED/BROKE." THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. PER CLARIFICATION RECEIVED ON 03/07/2022 THE CUTTING WIRE ANCHOR DISCONNECTED AT THE PATIENT END OF THE DEVICE. [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.

    Description of Event or Problem · 0

    THIS FOLLOW UP EMDR IS BEING SENT TO CANCEL THE INITIAL EMDR SUBMITTED. SEE H10 FOR JUSTIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498731 FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS COOK ENDOSCOPY G55814 W4549281 00827002558144

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown COOK METII-35-260 WIRE GUIDE| ERBE ELECTROSURGICAL GENERATOR| OLYMPUS DUODENOSCOPE, MODEL UNKNOWN