BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME

    MDR report key: 2043440 · Received February 25, 2011

    Report

    Report Number
    1037905-2011-00079
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Report Date
    January 28, 2011
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    KNS
    PMA / PMN Number
    K901443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. A REVIEW OF THE TWELVE MONTH COMPLAINT HISTORY FOR THIS PRODUCT FAMILY WAS CONDUCTED. THIS OCCURRENCE REPRESENTS AN UNUSUAL OCCURRENCE. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS TYPE OF REPORT IS REMOTE. 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. THE INSTRUCTIONS FOR USE CAUTION THE USER THAT ANY ELECTROSURGICAL ACCESSORY DEVICE CONSTITUTES A POTENTIAL ELECTRICAL HAZARD TO THE PT AND OPERATOR. FULGURATION AND BURNS ARE LISTED IN THE INSTRUCTIONS FOR USE AS POSSIBLE ADVERSE EFFECTS. IN ORDER TO PERFORM A SPHINCTEROTOMY, A SPHINCTEROTOME CUTS AND BURNS BY USE OF THE POWER PROVIDED BY THE ELECTROSURGICAL UNIT (SPECIFICALLY, THE ELECTROSURGICAL UNIT IS USED TO APPLY CAUTERY THROUGH THE SPHINCTEROTOME). THEREFORE, CUTTING AND BURNING ARE EXPECTED OUTCOMES OF A SPHINCTEROTOMY. THE CONDITIONS IN WHICH THE SPHINCTEROTOME IS USED TO SAFELY CREATE THE DESIRED CUT AND BURN ARE UNDER THE DIRECT CONTROL OF THE USER. THE OBSERVATION OF A FLASH DURING SPHINCTEROTOMY IS A COMMON OCCURRENCE WHEN CAUTERY IS APPLIED TO THE CUTTING WIRE AND IT IS MAKING CONTACT WITH THE TISSUE TO PERFORM THE SPHINCTEROTOMY. A FLASH DURING SPHINCTEROTOMY IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH; THIS IS SIMPLY AN INDICATION THAT CAUTERY HAS BEEN APPLIED TO THE CUTTING WIRE AND THE CUTTING WIRE IS IN CONTACT WITH TISSUE. PRIOR TO DISTRIBUTION, ALL COOK ENDOSCOPY TRI-TOME PC PROTECTOR TRIPLE LUMEN SPHINCTEROTOME ARE SUBJECTED TO A VISUAL AND FUNCTIONAL TEST TO ENSURE DEVICE INTEGRITY. THE FUNCTIONAL TEST INCLUDES VERIFICATION OF THE OHM METER IS USED TO VERIFY CONTINUITY BETWEEN THE CUTTING WIRE AND ELECTRICAL PIN. CORRECTIVE ACTION: NO CORRECTIVE ACTION WARRANTED AT THIS TIME BECAUSE THE REPORT WAS UNABLE TO BE VERIFIED. THE COMPLAINT RISK PRIORITY NUMBER (CRPN) FOR THIS TYPE OF OCCURRENCE HAS BEEN CALCULATED BASED ON THE RATE OF OCCURRENCE AND SEVERITY OF THE OUTCOME. BASED ON THIS ACTIVITY, NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. THIS OBSERVATION REPRESENTS AN UNUSUAL OCCURRENCE. THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS REMOTE. CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME. WHEN THE PHYSICIAN PERFORMED THE SPHINCTEROTOMY, THE CUTTING WIRE BURNED AND DID NOT CUT. THE SPHINCTEROTOME WAS REMOVED FROM THE ENDOSCOPE. ANOTHER SPHINCTEROTOME WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ANY ADDITIONAL 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 TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS WILSON-COOK MEDICAL INC W2911725

    Patients

    Seq Age Sex Outcome Treatment
    1 ERBE ELECTROSURGICAL UNIT (UNKNOWN MODEL NUMBER)| OLYMPUS ENDOSCOPE (UNKNOWN MODEL NUMBER)