BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 3771338 · Received April 24, 2014

    Report

    Report Number
    0001056128-2014-00053
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 14, 2014
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
    Product Code
    NUJ
    PMA / PMN Number
    K111600
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED SATING THE DEVICE WAS GETTING STUCK ON THE PATIENT¿S TISSUE DURING USE. THIS HOWEVER, DID NOT LEAD TO ANY ADVERSE CONSEQUENCES. THE COMPLAINT DEVICE WAS RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS (SSS) FOR AN 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. THE REPORTED ISSUE WAS SUBSTANTIATED AS 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 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 CONSECUTIVE CUTS WITHOUT ANY BUNCHING; FRAYING; INCOMPLETE OR UNCLEAN CUTS. THE RESULTS OF THE INVESTIGATION PERFORMED INDICATED THAT THE JAWS OF THE RETURNED DEVICE WERE STUCK IN THE CLOSED POSITION AS THE BLADE WAS DISLOCATED FROM THE GUIDING SLOTS. THE LOCKED JAWS AND DISLOCATED BLADE MOST LIKELY RESULTED FROM GRASPING A GREATER AMOUNT OF TISSUE THAN THE DEVICE INTENDED FOR AND THEN ATTEMPTING CUT IT. THEREFORE, THE FAILURE WAS DETERMINED TO BE A RESULT OF CLINICAL TECHNIQUE. STRYKER SUSTAINABILITY SOLUTIONS' 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.¿ ¿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.¿ ¿PRIOR TO ACTIVATING THE CUTTER, CONFIRM THAT THE JAWS ARE IN THE CLOSED POSITION. SPACING BETWEEN JAWS MUST BE LESS THAN TWO MILLIMETERS.¿ THE LOT CONTROL SHEET FOR THE COMPLAINT DEVICE INDICATES THAT THE 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 0001056128-2013-00079 FILED ON (B)(6) 2013 WHERE THE BLADE DERAILED AND LOCKED ON THE PATIENT'S TISSUE AND HAD TO BE CUT OFF EVEN THOUGH THERE WAS NO PATIENT INJURY REPORTED 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 LIGASURE IMPACT, "BLADE WOULD NOT RETRACT." THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. THERE WAS NO MEDICAL TREATMENT OR INTERVENTION REQUIRED AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249402 LIGASURE IMPACT ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC NUJ STRYKER SUSTAINABILITY SOLUTIONS LAKELAND LF4200RR 2753026

    Patients

    Seq Age Sex Outcome Treatment
    1