BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION OMNI-TOME SPHINCTEROTOME

    MDR report key: 1970917 · Received January 5, 2011

    Report

    Report Number
    1037905-2010-00714
    Event Type
    Malfunction
    Date Received
    January 5, 2011
    Date of Event
    August 23, 2010
    Report Date
    September 28, 2010
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    KNS
    PMA / PMN Number
    K052051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: OUR LAB EVAL OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE CUTTING WIRE SECURING COMPONENT DISCONNECTED FROM THE CATHETER AT THE DISTAL END. THE CUTTING WIRE REMAINS SECURELY ATTACHED TO THE SPHINCTEROTOME AT THE PROXIMAL END. NO SECTION OF THE CUTTING WIRE IS MISSING. A PRODUCT DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THIS REPORTED OCCURRENCE WAS NOT OBSERVED. WE COULD NOT CONDUCT A REVIEW OF THE DEVICE HISTORY RECORD OR CONDUCT A SAMPLE TEST FROM THIS LOT BECAUSE THE LOT NUMBER WAS NOT PROVIDED. AFTER A REVIEW OF THE ACCOUNT ORDERING AND SHIPPING HISTORY, THE LOT NUMBER COULD NOT BE DETERMINED. A REVIEW OF THE 12 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 ADD'L 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. CORRECTIVE ACTION: A CORRECTIVE ACTION HAS BEEN INITIATED IN AN EFFORT TO REDUCE OCCURRENCES OF THIS NATURE. BASED ON THE DATE OF THIS REPORT, WE CAN CONFIRM THAT THIS PRODUCT WAS MFG PRIOR TO IMPLEMENTATION OF THE 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 09/07/2010, THE FOLLOWING INFO WAS PROVIDED TO COOK ENDOSCOPY: DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK ENDOSCOPY FUSION OMNI-TOME SPHINCTEROTOME. THE SPHINCTEROTOME CUTTING WIRE REPORTEDLY BROKE DURING USE. THIS INFO DID NOT REASONABLY SUGGEST A REPORTABLE EVENT HAD OCCURRED. ON 09/28/2010, THE DEVICE WAS RETURNED FOR EVAL. UPON EVAL, 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. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ANY ADD'L PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUSION OMNI-TOME SPHINCTEROTOME KNS, ENDOSCOPIC ELECTROSURGICAL UNIT AND ACCESSORIES KNS COOK ENDOSCOPY UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS ENDOSCOPE (UNK MODEL NUMBER)| ACTIVE CORD (UNK TYPE)| ELECTROSURGICAL GENERATOR (UNK TYPE)