BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME

    MDR report key: 1935815 · Received December 3, 2010

    Report

    Report Number
    1037905-2010-00676
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    October 13, 2010
    Report Date
    October 13, 2010
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    KNS
    PMA / PMN Number
    K052051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION IN THIS REPORT WAS PROVIDED TO US BY OUR DISTRIBUTOR IN (B)(4) ON BEHALF OF A MEDICAL FACILITY IN (B)(6). (B)(6). EVALUATION: OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE CUTTING WIRE SECURING COMPONENT LOCATED NEAR THE DISTAL END OF THE SPHINCTEROTOME HAD 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. NO SECTION OF THE SPHINCTEROTOME DEVICE IS MISSING. A PRODUCT DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THIS REPORTED OCCURRENCE WAS NOT OBSERVED. AFTER A REVIEW OF THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED, WE CAN REPORT NO DISCREPANCIES OR ANOMALIES WERE OBSERVED. WE WERE UNABLE TO CONDUCT A SAMPLE TEST FROM THIS LOT BECAUSE NONE OF THE PRODUCT FROM THIS LOT REMAINED IN FINISHED GOODS INVENTORY. A REVIEW OF THE TWELVE MONTH COMPLAINT HISTORY FOR THIS PRODUCT FAMILY WAS CONDUCTED. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS TYPE OF REPORT IS RARE. CONCLUSIONS: 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 NOT TO OVER FLEX OR BOW THE TIP BEYOND 90 DEGREES, AS THIS MAY DAMAGE THE SPHINCTEROTOME. THIS TYPE OF DAMAGE CAN OCCUR IF THE DISTAL END OF THE CATHETER IS SHAPED MANUALLY. THIS SPHINCTEROTOME CATHETER IS PRE-CURVED AND IS PROVIDED WITH A PRE-CURVED STYLET IN THE DISTAL TIP OF THE CATHETER. THIS OBVIATES THE NEED FOR MANUAL FORMATION. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING COMMENT: "NOTE: DO NOT APPLY MANUAL PRESSURE TO TIP OR CUTTING WIRE OF THE SPHINCTEROTOME TO INFLUENCE ORIENTATION, AS THIS MAY RESULT IN DAMAGE TO DEVICE." 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 SEPARATION OF THE CATHETER AND CUTTING WIRE SECURING COMPONENT. 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. 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 PRE-CURVED 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 PRE-CURVED STYLET FROM THE CANNULATING TIP. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING COMMENT: "NOTE: DO NOT EXERCISE HANDLE WHILE DEVICE IS COILED OR PRE-CURVED 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. 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 CORRECTIVE ACTION HAS BEEN INITIATED IN A EFFORT TO REDUCE OCCURRENCES OF THIS NATURE. THIS PRODUCT WAS MANUFACTURED PRIOR TO IMPLEMENTATION OF THIS CORRECTIVE ACTION. THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS RARE. CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE FOLLOWING INFORMATION WAS PROVIDED TO COOK ENDOSCOPY: DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ENDOSCOPY FUSION OMNI-TOME SPHINCTEROTOME. WHEN CAUTERY WAS APPLIED TO PERFORM THE SPHINCTEROTOMY, THE SPHINCTEROTOME CUTTING WIRE REPORTEDLY BROKE. THIS INFORMATION DID NOT REASONABLY SUGGEST A REPORTABLE EVENT HAD OCCURRED. ON (B)(6) 2010, THE DEVICE WAS RETURNED FOR EVALUATION. UPON EVALUATION, WE CONFIRMED THE CUTTING WIRE TO BE INTACT. HOWEVER, THE CUTTING WIRE SECURING COMPONENT LOCATED AT THE DISTAL END OF THE CUTTING WIRE DISCONNECTED FROM THE SPHINCTEROTOME CATHETER. NO SECTION OF THE CUTTING WIRE SECURING COMPONENT IS MISSING. THE INITIAL REPORTER INDICATED NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. ADDITIONAL INFORMATION PROVIDED INDICATED THE PATIENT REQUIRED AN EXTRA ERCP PROCEDURE. THIS IS A CONTINUATION OF THE ORIGINALLY PLANNED PROCEDURE, AND IS NOT A PROCEDURE TO PRECLUDE DEATH OR SERIOUS INJURY. A DEATH OR SERIOUS INJURY DID NOT OCCUR IN THIS CASE, AND THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME KNS, ENDOSCOPIC ELECTROSURGERY ACCESSORY KNS COOK ENDOSCOPY W2899874

    Patients

    Seq Age Sex Outcome Treatment
    1 ERBE ELECTROSURGICAL UNIT, ACTIVE CORD (UNK TYPE)| 4.2 MM PENTAX DUODENOSCOPE (UNKNOWN TYPE)