BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3071555 · Received April 22, 2013

    Report

    Report Number
    0001056128-2013-00046
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 27, 2013
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
    Product Code
    NUJ
    PMA / PMN Number
    K111600
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED ESCHAR BUILD-UP IN THE GUIDING SLOTS AND A DERAILED BLADE PROTRUDING FROM THE JAW. THE JAWS WERE UNABLE TO OPEN SINCE THE BLADE WAS DISLOCATED/NOT FULLY RETRACTED. 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, LOCKED/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 MOVEMENT AND DID NOT DERAIL WHEN ACTIVATED; HOWEVER, THE BLADE TRIGGER EXHIBITED A STICKY FEEL THE FIRST ACTIVATION AS A RESULT OF THE ESCHAR BUILD-UP. AFTER THE FIRST BLADE TRIGGER ACTIVATION, THE BLADE WAS ABLE TO FUNCTION AS INTENDED AND DID NOT STICK ANYMORE. THE DEVICE WAS THEN CONFIRMED TO PASS CUT TESTING AS IT WAS ABLE TO SUCCESSFULLY MAKE THREE CONSECUTIVE CUTS WITHOUT ANY BUNCHING; FRAYING; OR MAKING INCOMPLETE AND/OR UNCLEAN CUTS ON TYVEK MATERIAL. BASED ON THE EVALUATION OF THE DEVICE, THIS TYPE OF FAILURE CAN BE CAUSED BY CLAMPING ON LARGE, RIGID TISSUE. THE DESIGN OF THE LF4200 ALLOWS FOR LARGER BITES OF TISSUE THAN OTHER DEVICES. HOWEVER, IT IS CRITICAL 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 OR INJURY RESULTING TO THE USER OR PATIENT. SSS INSTRUCTIONS FOR USE STATES: "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." "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." "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. THIS REPORT IS BEING FILED AS A MALFUNCTION DUE TO SSS BEING IN A 2 YEAR REPORTING CYCLE DUE TO MDR REPORT 1056128-2012-00042, WHERE THE DEVICE HAD TO BE CUT AWAY FROM THE PATIENT'S TISSUE WHEN IT BECAME STUCK 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 THE JAW OF THE LIGASURE DEVICE "LOCKED AND WAS NOT ABLE TO BE REOPENED." NO PATIENT INJURY WAS REPORTED BY THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171282 NA NUJ NUJ STRYKER SUSTAINABILITY SOLUTIONS LAKELAND LF4200 2331897

    Patients

    Seq Age Sex Outcome Treatment
    1