BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 5995418 · Received October 3, 2016

    Report

    Report Number
    0001056128-2016-00131
    Event Type
    Injury
    Date Received
    October 3, 2016
    Date of Event
    September 6, 2016
    Report Date
    September 7, 2016
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
    Product Code
    NUJ
    PMA / PMN Number
    K150538
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS FOR EVALUATION. THE RETURNED COMPLAINT DEVICE WAS RECEIVED WITH THE STRYKER SUSTAINABILITY PACKAGING. THERE WAS EVIDENCE OF BIO-BURDEN PRESENT ON THE DEVICE. A REVIEW OF THE DHR FOR THE REPORTED LOT/SERIAL NUMBER SUPPORTS THAT THE DEVICE MET ALL INSPECTION AND TEST CRITERIA PRIOR TO RELEASE FROM STRYKER. THE REPORTED EVENT COULD BE ATTRIBUTED TO: ANCILLARY EQUIPMENT FAILURE. THUMB TRIGGER BUTTON (ACTIVATION BUTTON) NOT ENGAGED THROUGHOUT THE ENTIRE SEAL CYCLE. DEVICE USED ON VESSELS THICKER THAN 7 MM. ESCHAR BUILD UP ON DEVICE JAWS AFFECTING PERFORMANCE. THE INSTRUCTIONS FOR USE (IFU) STATE: THE LF4318 INSTRUMENT IS INTENDED FOR USE ONLY WITH THE COVIDIEN FORCETRIAD ENERGY PLATFORM. USE OF THIS INSTRUMENT WITH OTHER COVIDIEN GENERATORS OR WITH GENERATORS PRODUCED BY OTHER MANUFACTURERS MAY NOT RESULT IN THE DESIRED TISSUE EFFECT, MAY RESULT IN INJURY TO THE PATIENT OR SURGICAL TEAM, OR MAY CAUSE DAMAGE TO THE INSTRUMENT. DO NOT USE THE LIGASURE SYSTEM UNLESS PROPERLY TRAINED TO USE IT IN THE SPECIFIC PROCEDURE BEING UNDERTAKEN. USE OF THIS EQUIPMENT WITHOUT SUCH TRAINING MAY RESULT IN SERIOUS UNINTENDED PATIENT INJURY. USE CAUTION DURING SURGICAL CASES IN WHICH PATIENTS EXHIBIT CERTAIN TYPES OF VASCULAR PATHOLOGY (ATHEROSCLEROSIS, ANEURYSMAL VESSELS, ETC.). FOR BEST RESULTS, APPLY THE SEAL TO UNAFFECTED VASCULATURE. DO NOT USE THIS INSTRUMENT ON VESSELS IN EXCESS OF 7 MM IN DIAMETER. SELECT THE APPROPRIATE BAR SETTING TO ACHIEVE THE DESIRED TISSUE EFFECT. THIS SETTING MAY NEED TO BE ADJUSTED DURING THE PROCEDURE. 1 GREEN BAR - USE ON ISOLATED OR SMALL TISSUE BUNDLES, 2 GREEN BARS - USE WITH AVERAGE TISSUE BUNDLES, 3 GREEN BARS - USE ON LARGER TISSUE BUNDLES (THIS SETTING MAY SLIGHTLY INCREASE FUSION TIMES.) NOTE: THE SYSTEM DETECTS THE CONNECTED LIGASURE INSTRUMENT AND SETS THE INTENSITY SETTING TO 2 BARS IN THE DISPLAY. IF SETTINGS ARE ENTERED IN THE LIGASURE TOUCHSCREEN PRIOR TO CONNECTING THE LIGASURE INSTRUMENT, THESE SETTINGS WILL BE RESET TO 2 BARS. PLACE THE VESSEL OR TISSUE IN THE CENTER OF THE JAWS. TO AVOID INCOMPLETE SEALING, DO NOT GRASP TISSUE BEYOND THE ELECTRODE SURFACE; DO NOT PLACE TISSUE IN THE JAW HINGE. CONTACT BETWEEN AN ACTIVE INSTRUMENT ELECTRODE AND ANY METAL OBJECT (HEMOSTATS, STAPLES, CLIPS, RETRACTORS, ETC.) MAY INCREASE CURRENT FLOW AND CAN RESULT IN UNINTENDED SURGICAL EFFECTS, SUCH AS AN EFFECT AT AN UNINTENDED SITE OR INSUFFICIENT ENERGY DISPOSITION. DO NOT ACTIVATE RF ENERGY UNTIL THE HANDLE HAS BEEN PROPERLY LATCHED. ACTIVATING THE DEVICE BEFORE THIS IS DONE MAY RESULT IN IMPROPER SEALING AND MAY INCREASE THERMAL SPREAD TO TISSUE OUTSIDE THE SURGICAL SITE. DO NOT ACTIVATE THE INSTRUMENT WHILE IN CONTACT WITH OR NEAR OTHER INSTRUMENTS, INCLUDING CANNULAS. LOCALIZED BURNS TO THE PATIENT OR PHYSICIAN MAY OCCUR. DO NOT ATTEMPT TO SEAL OVER CLIPS OR STAPLES AS THIS MAY RESULT IN AN INCOMPLETE SEAL. IF THE SEAL-CYCLE COMPLETE TONE HAS NOT SOUNDED, AN OPTIMAL SEAL MAY NOT HAVE BEEN REACHED. REACTIVATE THE RF ENERGY UNTIL A SEAL-COMPLETE TONE IS HEARD. OPEN THE JAWS BY PUSHING FORWARD THE WHITE, MOVABLE HANDLE. GRASP THE INTENDED VESSEL AND/OR TISSUE IN THE CENTER OF THE JAWS. CLOSE THE HANDLE UNTIL IT CLICKS AND LATCHES IN PLACE. ACTIVATE THE INSTRUMENT BY EITHER OF THE FOLLOWING METHODS: PRESS AND HOLD THE PURPLE ACTIVATION BUTTON ON THE BACK OF THE INSTRUMENT. DEPRESS AND HOLD THE CORRESPONDING ROUND, PURPLE OR ORANGE PEDAL ON THE FOOTSWITCH. A CONTINUOUS TONE SOUNDS TO INDICATE THAT THE VESSEL OR TISSUE IS BEING SEALED. WHEN THE ACTIVATION CYCLE IS COMPLETE, A DOUBLE END TONE SOUNDS AND THE ENERGY PLATFORM DISCONTINUES RF OUTPUT. RELEASE THE PURPLE ACTIVATION BUTTON ON THE INSTRUMENT, OR THE PURPLE OR ORANGE FOOT PEDAL WHEN THE SEAL CYCLE IS COMPLETE. TO SEAL ADJACENT TISSUE, OVERLAP THE EDGE OF THE EXISTING SEAL. THE SECOND SEAL SHOULD BE DISTAL TO THE FIRST SEAL TO INCREASE SEAL MARGIN. FAILURE TO OVERLAP SEALS WHEN A SECOND SEAL IS DESIRED MAY COMPROMISE SEAL INTEGRITY. KEEP THE INSTRUMENT JAWS CLEAN. BUILD-UP OF ESCHAR MAY REDUCE SEALING AND/OR CUTTING EFFECTIVENESS. WIPE JAWS SURFACES AND EDGES WITH A STERILE, WATER OR SALINE SOAKED GAUZE PAD AS NEEDED. DO NOT CLEAN INSTRUMENT JAWS WITH A SCRATCH PAD. THE REPORTED EVENT WILL CONTINUE TO BE MONITORED THROUGH POST-MARKET SURVEILLANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LIGASURE WOULD NOT SEAL WHICH LED TO BLEEDING. THE VESSEL WAS SUTURED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644404 NA ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, R NUJ STRYKER SUSTAINABILITY SOLUTIONS LAKELAND LF4318 4104789

    Patients

    Seq Age Sex Outcome Treatment
    1