BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME

    MDR report key: 2080976 · Received April 13, 2011

    Report

    Report Number
    1037905-2011-00231
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Report Date
    March 14, 2011
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    KNS
    PMA / PMN Number
    K052051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION IN THIS REPORT WAS PROVIDED TO US BY THE COOK FACILITY IN (B)(4) ON BEHALF OF A MEDICAL FACILITY IN THE (B)(6). (B)(4). 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. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. A SAMPLE TEST FROM THIS LOT COULD NOT BE CONDUCTED BECAUSE NONE OF THE PRODUCT FROM THIS LOT REMAINED IN INVENTORY. CONCLUSIONS: 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. IMPROPER CUTTING WIRE ORIENTATION 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." OTHER FACTORS THAT CAN CONTRIBUTE TO IMPROPER CUTTING WIRE ORIENTATION 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 PRE-LOADED SPHINCTEROTOME ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TEST TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: THIS TYPE OF OCCURRENCE HAS BEEN BROUGHT TO THE ATTENTION OF THE APPROPRIATE INTERNAL PERSONNEL IN AN EFFORT TO HEIGHTEN AWARENESS. NO FURTHER ACTION WAS TAKEN AT THIS TIME. CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME. INCORRECT CUTTING WIRE ORIENTATION WAS OBSERVED DURING USE. SEVERAL ATTEMPTS WERE MADE IN AN ATTEMPT TO COLLECT ADDITIONAL INFORMATION REGARDING PATIENT IMPACT AND PRODUCT USAGE. THE COMPLAINANT DID NOT SPECIFY IF THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS OR REQUIRED ADDITIONAL MEDICAL PROCEDURES DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS WILSON-COOK MEDICAL INC W2950512

    Patients

    Seq Age Sex Outcome Treatment
    1 ACTIVE CORD: (UNKNOWN TYPE)| ENDOSCOPE: (UNKNOWN TYPE)| ELECTROSURGICAL UNIT: (UNKNOWN TYPE)