BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 5997193 · Received October 4, 2016

    Report

    Report Number
    0001056128-2016-00133
    Event Type
    Injury
    Date Received
    October 4, 2016
    Date of Event
    September 2, 2016
    Report Date
    September 7, 2016
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
    Product Code
    NUJ
    PMA / PMN Number
    K133578
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS FOR EVALUATION. THE COMPLAINT DEVICE WAS RETURNED WITH THE STRYKER SUSTAINABILITY TRAY. THERE WAS EVIDENCE OF BIO-BURDEN PRESENT ON THE DEVICE. A REVIEW OF THE DHR FOR THE REPORTED LOT/SERIAL NUMBER SUPPORTS THAT THE DEVICE MET ALL INSPECTION AND TEST CRITERIA PRIOR TO RELEASE FROM STRYKER. THE REPORTED EVENT COULD BE ATTRIBUTED TO: ANCILLARY EQUIPMENT FAILURE, THUMB TRIGGER BUTTON (ACTIVATION BUTTON) NOT ENGAGED THROUGHOUT THE ENTIRE SEAL CYCLE, DEVICE USED ON VESSELS THICKER THAN 7 MM, ESCHAR BUILD UP ON DEVICE JAWS AFFECTING PERFORMANCE. THE INSTRUCTIONS FOR USE (IFU) STATE: THE LF1637 INSTRUMENT IS INTENDED FOR USE ONLY WITH THE COVIDIEN FORCE TRIAD ENERGY PLATFORM. USE OF THIS INSTRUMENT WITH OTHER COVIDIEN GENERATORS OR WITH GENERATORS PRODUCED BY OTHER MANUFACTURERS MAY NOT RESULT IN THE DESIRED TISSUE EFFECT, MAY RESULT IN INJURY TO THE PATIENT, OR SURGICAL TEAM, OR MAY CAUSE DAMAGE TO THE INSTRUMENT. THESE INSTRUMENTS ARE ONLY INTENDED FOR USE BY INDIVIDUALS WITH ADEQUATE TRAINING AND FAMILIARITY WITH THE SPECIFIC PROCEDURE BEING UNDERTAKEN. USE OF THIS EQUIPMENT WITHOUT SUCH TRAINING MAY RESULT IN SERIOUS UNINTENDED PATIENT INJURY. FOR FURTHER INFORMATION ABOUT TECHNIQUES, COMPLICATIONS AND HAZARDS, CONSULT THE MEDICAL LITERATURE. CONTACT BETWEEN AN ACTIVE INSTRUMENT ELECTRODE AND ANY METAL OBJECTS (HEMOSTATS, STAPLES, CLIPS, RETRACTORS, ETC.) MAY INCREASE CURRENT FLOW AND MAY RESULT IN UNINTENDED SURGICAL EFFECTS, SUCH AS AN EFFECT AT AN UNINTENDED SITE OR INSUFFICIENT ENERGY DEPOSITION. BEFORE BEGINNING THE PROCEDURE, VERIFY OVERALL COMPATIBILITY OF ALL INSTRUMENTS AND ACCESSORIES. INSPECT THE INSTRUMENT FOR OVERALL CONDITION AND PHYSICAL INTEGRITY. DO NOT USE THE INSTRUMENT IF ANY DAMAGE IS NOTED. RETURN THE INSTRUMENT AND PACKAGING TO STRYKER IF IT IS NOT IN ACCEPTABLE CONDITION FOR THE PROCEDURE. EXAMINE ALL LIGASURE SYSTEM AND INSTRUMENT CONNECTIONS BEFORE USING. IMPROPER CONNECTION MAY RESULT IN ARCING, SPARKS, ACCESSORY MALFUNCTION, OR UNINTENDED SURGICAL EFFECTS. INSPECT THE INSTRUMENT AND CORDS FOR BREAKS, CRACKS, NICKS, OR OTHER DAMAGE BEFORE USE. FAILURE TO OBSERVE THIS CAUTION MAY RESULT IN INJURY OR ELECTRICAL SHOCK TO THE PATIENT OR SURGICAL TEAM OR CAUSE DAMAGE TO THE INSTRUMENT. IF DAMAGED, DO NOT USE. THE LIGASURE SYSTEM DETECTS THE INSTRUMENT TYPE AND SETS THE INTENSITY SETTING TO 2 BARS IN THE DISPLAY. IF YOU HAVE ENTERED SETTINGS IN THE LIGASURE TOUCHSCREEN PRIOR TO CONNECTING THE LIGASURE INSTRUMENT, THESE SETTINGS WILL BE RESET TO 2 BARS. THIS SETTING MAY NEED TO BE ADJUSTED DURING THE PROCEDURE. THE INTENSITY SETTINGS ARE USED AS FOLLOWS: ONE (1) GREEN BAR ¿ ISOLATED, SMALL TISSUE BUNDLES. TWO (2) GREEN BARS ¿ AVERAGE TISSUE BUNDLES. THREE (3) GREEN BARS ¿ LARGER TISSUE BUNDLES (THIS WILL INCREASE FUSION TIMES). DO NOT USE THIS INSTRUMENT ON VESSELS LARGER THAN 7 MM IN DIAMETER. DO NOT PLACE THE VESSEL AND/OR TISSUE IN THE JAW HINGE. PLACE THE VESSEL AND/OR TISSUE IN THE CENTER OF THE JAWS. USE CAUTION WHEN GRASPING, MANIPULATING, SEALING, AND DIVIDING LARGE TISSUE BUNDLES. DO NOT ACTIVATE THE INSTRUMENT WHILE INSTRUMENT JAWS ARE IN CONTACT WITH, OR IN CLOSE PROXIMITY TO, OTHER INSTRUMENTS INCLUDING METAL CANNULAS, AS LOCALIZED BURNS TO THE PATIENT OR PHYSICIAN MAY OCCUR. DO NOT ACTIVATE THE LIGASURE SYSTEM UNTIL THE LEVER HAS BEEN LATCHED. ACTIVATING THE SYSTEM BEFORE LATCHING MAY RESULT IN IMPROPER SEALING AND MAY INCREASE THERMAL SPREAD TO TISSUE OUTSIDE OF THE SURGICAL SITE. ENERGY-BASED DEVICES, SUCH AS ES PENCILS OR ULTRASONIC SCALPELS THAT ARE ASSOCIATED WITH THERMAL SPREAD, SHOULD NOT BE USED TO TRANSECT SEALS. THE REPORTED EVENT WILL CONTINUE TO BE MONITORED THROUGH POST-MARKET SURVEILLANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LIGASURE WAS NOT SEALING PROPERLY AND CAUSED A HEMATOMA. THE HEMATOMA WAS NOT LIFE-THREATENING AND NO BLOOD TRANSFUSION WAS REQUIRED. THERE WAS NO MEDICAL INTERVENTION OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649041 NA ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, R NUJ STRYKER SUSTAINABILITY SOLUTIONS LAKELAND LF1637 4467495

    Patients

    Seq Age Sex Outcome Treatment
    1