BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3808861 · Received May 13, 2014

    Report

    Report Number
    0001056128-2014-00055
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Date of Event
    April 21, 2014
    Report Date
    April 25, 2014
    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 EVALUATION. THE DEVICE WAS RECEIVED WITH A DERAILED BLADE, ESCHAR BUILD-UP IN THE GUIDING SLOTS, AND VISIBLE BIOLOGICAL MATERIAL ON THE JAWS, EVIDENCE THAT IT WAS CLINICALLY USED. HOWEVER, THE REPORTED EVENT WAS UNABLE TO BE SUBSTANTIATED AS NOTHING WAS BROKEN OFF THE DEVICE. THE BLADE WAS ABLE TO BE REALIGNED INTO THE GUIDING SLOTS; THEREFORE, FUNCTIONAL TESTING COULD BE PERFORMED. THE JAW FUNCTIONALITY WAS TESTED AND CONFIRMED TO BE ACCEPTABLE AS IT WAS ABLE TO ACTUATE, LOCK/UNLOCK MULTIPLE TIMES. WHILE THE JAWS WERE IN THE LOCKED POSITION THEY WERE INSPECTED AND FOUND TO BE ALIGNED. THE BLADE TRIGGER WAS TESTED AND VERIFIED TO MAINTAIN SMOOTH MOVEMENT AND DID NOT STICK OR DERAIL WHEN ACTIVATED. THE DEVICE WAS THEN CONFIRMED TO PASS CUT TESTING AS IT WAS ABLE TO SUCCESSFULLY MAKE THREE (3) CONSECUTIVE CUTS WITHOUT ANY BUNCHING, FRAYING, OR INCOMPLETE OR UNCLEAN CUTS ON TYVEK MATERIAL. BASED ON SSS ENGINEERING EVALUATIONS, THE BLADE CAN DERAIL BY CLAMPING ON LARGE RIGID TISSUE. DESIGN OF THE LF4200 ALLOWS FOR LARGER BITES OF TISSUE THAN OTHER DEVICES. IT IS CRITICAL, HOWEVER, THAT THE USER DOES NOT PLACE TOO MUCH TISSUE IN THE JAWS DURING USE. IF THE JAWS ARE OVERFILLED, IT IS POSSIBLE FOR THE CUTTING MECHANISM TO BE DAMAGED, POTENTIALLY RESULTING IN DIFFICULTY OPENING THE JAWS. BEFORE ACTIVATING THE CUTTER, THE USER MUST VISUALLY CONFIRM THAT THE TIPS OF THE JAWS ARE FULLY CLOSED FOLLOWING THE TISSUE FUSION CYCLE. IF THE TIPS OF THE JAWS ARE NOT FULLY CLOSED, IT IS POSSIBLE FOR THE CUTTING MECHANISM TO BE DAMAGED, POTENTIALLY RESULTING IN DIFFICULTY OPENING THE JAWS. SSS INSTRUCTIONS FOR USE 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.¿ ¿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.¿ ¿PRIOR TO ACTIVATING THE CUTTER, CONFIRM THAT THE JAWS ARE IN THE CLOSED POSITION. SPACING BETWEEN JAWS MUST BE LESS THAN TWO MILLIMETERS.¿ THE DEVICE HISTORY RECORD FOR THE RETURNED DEVICE INDICATES THAT THE COMPLAINT DEVICE PASSED ALL APPLICABLE INSPECTIONS AND TESTS PRIOR TO RELEASE. 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 HAND PIECE BROKE OFF." THE CASE WAS ALMOST COMPLETED AT THE TIME THIS OCCURRED AND WAS COMPLETED USING NON-ENERGY DEVICES. NO ADVERSE EVENTS WERE REPORTED BY THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286387 NA ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES NUJ STRYKER SUSTAINABILITY SOLUTIONS LAKELAND LF4200 2850097

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR