BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3822072 · Received May 20, 2014

    Report

    Report Number
    0001056128-2014-00059
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 9, 2014
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
    Product Code
    NUJ
    PMA / PMN Number
    K111600
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS (SSS) FOR EVALUATION. INSPECTION OF THE RETURNED DEVICE REVEALED BIOLOGICAL MATERIAL ON THE DISTAL TIP. THE DEVICE JAWS WERE NOT ACTUATING. ACTUATION OF THE BLADE WAS ALSO INEFFECTIVE AS THE BLADE WOULD NOT ACTUATE AND THE TRIGGER WOULD NOT MOVE. THE DEVICE WAS TAKEN APART AND THE BLADE ACTUATION TRIGGER WAS SEEN TO BE DISCONNECTED FROM THE BLADE CARRIAGE ASSEMBLY. THE BLADE ACTUATION TRIGGER WAS BLOCKED BY THE BLADE CARRIAGE CONNECTOR AND ONE OF THE CLIPS ON THE BLADE CARRIAGE CONNECTOR WAS BROKEN. FURTHERMORE, THE JAW ACTUATION TRIGGER WOULD NOT ACTUATE AS THE BLADE ACTUATION TRIGGER WAS BLOCKING IT. THEREFORE, THE REPORTED ISSUE WAS SUBSTANTIATED. BASED ON SSS ENGINEERING EVALUATIONS (AND OM EVALUATIONS), THE TYPE OF FAILURE REPORTED CAN BE CAUSED 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 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. THE CAUTERIZING CAPABILITY OF THE DEVICE COULD NOT BE TESTED AS THE DEVICE WAS RECEIVED WITH A CUT CORD; THEREFORE THIS ISSUE COULD NOT BE DUPLICATED. 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. THIS REPORT IS BEING FILED AS A MALFUNCTION DUE TO "COAGULATION ISSUES" 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 AN OPEN ABDOMEN PROCEDURE THE LIGASURE " WAS BEING USED TO SEAL AND SNIP A MAJOR ARTERY, AND WHEN THE DOCTOR GRASPED THE DEVICE TO CAUTERIZE, HE HEARD AN AUDIBLE 'POP/CRACK'. THE TRIGGER FAILED AND CAUSED AN INCOMPLETE CAUTERIZATION AND CUTTING OF THE VESSEL. THE DEVICE WAS RELEASED AND REPLACED INSTANTLY." IT WAS CONFIRMED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH MINIMAL DELAY. THERE WAS NO PATIENT INJURY, MEDICAL TREATMENT OR INTERVENTION REQUIRED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299774 NA ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES NUJ STRYKER SUSTAINABILITY SOLUTIONS LAKELAND LF4200 2808842/ 44551290

    Patients

    Seq Age Sex Outcome Treatment
    1