BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3163664 · Received June 11, 2013

    Report

    Report Number
    0001056128-2013-00090
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 16, 2013
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
    Product Code
    NUJ
    PMA / PMN Number
    K111600
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 A DERAILED BLADE. THE JAWS WERE UNABLE TO OPEN OR CLOSE 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 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 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. 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 CUTTER 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 (B)(4) 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 DURING A PROCEDURE "THE BLADE CAME OFF ITS TRACK," THE TRIGGER WOULDN'T WORK, AND THE HANDLE WOULDN'T OPEN THE JAWS OF THE LIGASURE DEVICE. NO PATIENT INJURY WAS REPORTED BY THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263745 NA NUJ NUJ STRYKER SUSTAINABILITY SOLUTIONS LAKELAND LF4200 2327225

    Patients

    Seq Age Sex Outcome Treatment
    1