BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3083663 · Received April 29, 2013

    Report

    Report Number
    0001056128-2013-00050
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    March 26, 2013
    Report Date
    April 2, 2013
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
    Product Code
    NUJ
    PMA / PMN Number
    K111600
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS (SSS) FOR AN EVALUATION. THE THUMB BUTTON FEEDBACK WAS TESTED AND FOUND TO BE ACCEPTABLE AS IT WAS ABLE TO DEPRESS THE PRESSURE PAD ON THE MEMBRANE SWITCH AND EXHIBITED A TACTILE CLICK; AND THE PRESSURE PAD DISENGAGED WHEN RELEASED. A CONTINUITY TEST WAS PERFORMED ON THE DEVICE AND FOUND PASS AS NO OPEN OR SHORT CIRCUIT CONDITIONS WERE IDENTIFIED WITHIN THE ELECTRICAL PATHS. THE DEVICE WAS THEN TESTED BY GRASPING PORK INTESTINE AND ENERGIZING IT FOR TWO CYCLES. THE DEVICE WAS RECOGNIZED BY THE GENERATOR AND THE DEFAULT NUMBER OF POWER BARS WERE DISPLAYED. THE INSTRUMENT WAS ENERGIZED WHILE GRASPING THE TEST MEDIUM UNTIL THE GENERATOR SIGNALED TO THE DEVICE THAT SEALING/COAGULATION WAS COMPLETE AND THEN AUTOMATICALLY SHUT OFF THE DEVICE. THE DEVICE WAS ABLE TO COMPLETE MULTIPLE CYCLES WITHOUT DISPLAYING ANY ERROR CODES AND WAS ABLE TO SEAL/COAGULATE/CUT AS INTENDED. A CONCLUSIVE ROOT CAUSE COULD NOT BE DETERMINED AS THE DEVICE SEALED AS INTENDED. HOWEVER, IT IS POSSIBLE THAT THE DEVICE WAS USED IN A WAY THAT WOULD AFFECT THE SEALING ABILITY (I.E. END USER TECHNIQUE RESULTING IN; OVERFILLING THE INSTRUMENT JAWS WITH TISSUE AND ATTEMPTING TO SEAL, SEALING OVER METAL OBJECTS SUCH AS SUTURES, CLIPS AND/OR STAPLES; NOT SELECTING THE APPROPRIATE BAR SETTING TO ACHIEVE THE DESIRED TISSUE EFFECT; NOT INSERTING THE LIGASMART CONNECTOR FIRMLY/COMPLETELY; IMPROPER CONNECTION, OR USING DEVICE WITH AN INCOMPATIBLE ACCESSORY). THE INSTRUCTIONS FOR USE (IFU) REPROCESSED HAND ACTIVATED SEALER/DIVIDER STATES: "DO NOT USE THIS DEVICE ON VESSELS IN EXCESS OF 7MM IN DIAMETER." "TO ENSURE PROPER FUNCTION, ELIMINATE TENSION ON THE TISSUE WHILE SEALING AND CUTTING." "PRIOR TO ACTIVATING THE CUTTER, CONFIRM THAT THE JAWS ARE IN THE CLOSED POSITION. SPACING BETWEEN JAWS MUST BE LESS THAN TWO MILLIMETERS." "GRASP THE INTENDED VESSEL AND/OR TISSUE IN THE CENTER OF THE JAWS. TO AVOID INCOMPLETE VESSEL SEALING, DO NOT GRASP TISSUE BEYOND THE ELECTRODE SURFACE; DO NOT PLACE TISSUE IN THE JAW HINGE." "CLOSE THE WHITE MOVABLE HANDLE UNTIL IT CLICKS AND LATCHES IN PLACE." "KEEP THE INSTRUMENT JAWS CLEAN. BUILD-UP OF ESCHAR MAY REDUCE SEALING AND/OR CUTTING EFFECTIVENESS. WIPE JAW SURFACES AND EDGES WITH A WET GAUZE PAD AS NEEDED." "AVOID OVERFILLING THE INSTRUMENT JAWS WITH TISSUE. THIS MAY DAMAGE THE CUTTING MECHANISM OR CAUSE THE BLADE TO DEPLOY OUTSIDE OF ITS GUIDING FEATURES, POSSIBLY RESULTING IN DIFFICULTY OPENING THE JAWS OR UNINTENDED INJURY TO THE USER OR PATIENT." "VISUALLY CONFIRM THAT THE JAWS HAVE REACHED THE CLOSED POSITION PRIOR TO ACTIVATING THE CUTTER. FAILURE TO DO SO MAY DAMAGE THE CUTTING MECHANISM OR CAUSE THE BLADE TO DEPLOY OUTSIDE OF ITS GUIDING FEATURES, POSSIBLY RESULTING IN DIFFICULTY OPENING THE JAWS OR UNINTENDED INJURY TO THE USER OR PATIENT." "KEEP THE INSTRUMENT JAWS CLEAN. BUILD-UP OF ESCHAR MAY REDUCE SEALING AND/OR CUTTING EFFECTIVENESS. WIPE JAW SURFACES AND EDGES WITH A WET GAUZE PAD AS NEEDED." "BEFORE STARTING THE PROCEDURE, CONFIRM PROPER ENERGY PLATFORM SETTINGS." "VERIFY COMPATIBILITY OF ALL INSTRUMENTS AND ACCESSORIES BEFORE THE BEGINNING OF THE PROCEDURE." " WITH THE BARCODE ON THE LIGASMART CONNECTOR FACING UP, FIRMLY INSERT IT INTO ONE OF THE HAND ACTIVATED SEALER DIVIDER RECEPTACLES UNDER THE RIGHT LIGASURE TOUCH SCREEN ON THE ENERGY PLATFORM FRONT PANEL." "PLACE THE VESSEL OR TISSUE IN THE CENTER OF THE JAWS. AVOID INCOMPLETE VESSEL SEALING BY NOT GRASPING TISSUE BEYOND THE ELECTRODE SURFACE OR PLACING IT IN THE JAW HINGE." "THE USER MUST SELECT THE APPROPRIATE BAR SETTING TO ACHIEVE THE DESIRED TISSUE EFFECT." "DO NOT ACTIVATE THE LIGASURE FUNCTION UNTIL THE HANDLE HAS BEEN PROPERLY LATCHED. ACTIVATING THE FUNCTION BEFORE THIS IS DONE MAY RESULT IN IMPROPER SEALING AND MAY INCREASE THERMAL SPREAD TO TISSUE OUTSIDE SURGICAL SITE." "DO NOT ATTEMPT TO SEAL OVER CLIPS OR STAPLES AS INCOMPLETE SEALS MAY BE FORMED." THE DEVICE HISTORY RECORD FOR THE RETURNED DEVICE INDICATES THAT THE COMPLAINT DEVICE PASSED ALL APPLICABLE INSPECTIONS AND TESTS PRIOR TO RELEASE. THIS REPORT IS BEING FILED AS A MALFUNCTION DUE TO SSS BEING IN A 2 YEAR REPORTING CYCLE DUE TO MDR REPORT 0001056128-2013-00015, WHERE AN ADDITIONAL PROCEDURE HAD TO BE PERFORMED DUE TO A VESSEL NOT BEING SEALED DURING THE ORIGINAL PROCEDURE, EVEN THOUGH THERE WAS NO PATIENT INJURY IN THIS EVENT. THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THE LIGASURE "WAS INDICATING THE TISSUE WAS SEALED BUT WHEN THE JAW RELEASED THE TISSUE WASN'T SEALED." THERE WAS NO PATIENT INJURY REPORTED BY THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185187 NA NUJ NUJ STRYKER SUSTAINABILITY SOLUTIONS LAKELAND LF4200 2067103

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR