BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3828287 · Received May 22, 2014

    Report

    Report Number
    0001056128-2014-00060
    Event Type
    Malfunction
    Date Received
    May 22, 2014
    Date of Event
    January 6, 2014
    Report Date
    April 28, 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

    AN INVESTIGATION HAS NOT BEEN COMPLETED FOR THIS EVENT. ONCE AN INVESTIGATION HAS BEEN COMPLETED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS (SSS) FOR EVALUATION. THE DEVICE WAS RECEIVED WITH VISIBLE BIOLOGICAL MATERIAL ON THE DISTAL TIP; EVIDENCE THAT IT WAS CLINICALLY USED. THE JAW FUNCTIONALITY WAS TESTED AND CONFIRMED TO BE ACCEPTABLE AS THE DEVICE WAS ABLE TO ACTUATE, LOCKED/UNLOCK MULTIPLE TIMES. WHILE THE JAWS WERE IN THE LOCKED POSITION, THEY WERE INSPECTED AND FOUND TO BE PROPERLY ALIGNED. THE BLADE TRIGGER WAS TESTED AND VERIFIED TO MAINTAIN PROPER 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 ANY INCOMPLETE OR UNCLEAN CUTS. THE RESULTS OF THE INVESTIGATION PERFORMED INDICATED THAT THE JAWS OF THE RETURNED DEVICE FUNCTIONED AS INTENDED AS IT WAS ABLE TO ACTUATE (LOCK/UNLOCK) AS INTENDED AND PASSED CUT TESTING. POTENTIAL CAUSES FOR THE REPORTED ISSUE CAN BE ATTRIBUTED BUT NOT LIMITED TO; ESCHAR BUILDUP INSIDE THE GUIDING SLOTS AND JAWS AS IT CAN INHIBIT THE GRASPING/CUTTING ABILITY AND POTENTIALLY CAUSE THE BLADE TO STICK/DRAG CAUSING THE BLADE TO DERAIL AND TEMPORARILY LOCK AS A RESULT OF OVER FILLING THE JAWS WITH TISSUE, AND THEN SUBSEQUENTLY REALIGNING WHILE MANIPULATING THE DEVICE IN THE PATIENT; OR UNKNOWN USER TECHNIQUES WHICH CAUSED THE DEVICE NOT TO CUT. THE INSTRUCTIONS FOR USE (IFU) REPROCESSED HAND ACTIVATED SEALER/DIVIDER 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.¿ ¿CLOSE THE WHITE MOVABLE HANDLE UNTIL IT CLICKS AND LATCHES IN PLACE.¿ ¿OPEN THE JAWS BY SQUEEZING THE WHITE MOVABLE HANDLE UNTIL IT UNLOCKS, THEN PUSH IT COMPLETELY FORWARD.¿ ¿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 RECORDS (DHR) FOR THE COMPLAINT DEVICE INDICATES THAT THE DEVICE PASSED ALL APPLICABLE INSPECTIONS AND TESTS PRIOR TO RELEASE. THIS REPORT WAS FILED DUE TO THE REPORTED EVENT BEING AN INHERENTLY DANGEROUS SITUATION. 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 "BLADES ARE CLOSED TOGETHER, WOULD NOT ACTIVATE AND WOULD NOT COAGULATE." THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO MEDICAL TREATMENT OR INTERVENTION REQUIRED AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THE LIGASURE "BLADES ARE CLOSED TOGETHER, WOULD NOT ACTIVATE AND WOULD NOT COAGULATE." THE PROCEDURE WAS COMPLETED SUCCESSFULLY. 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
    305782 NA ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES NUJ STRYKER SUSTAINABILITY SOLUTIONS LAKELAND LF4200 2843430

    Patients

    Seq Age Sex Outcome Treatment
    1