BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 6333182 · Received February 15, 2017

    Report

    Report Number
    0001056128-2017-00031
    Event Type
    Injury
    Date Received
    February 15, 2017
    Date of Event
    January 11, 2017
    Report Date
    February 15, 2017
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
    Product Code
    NUJ
    UDI-DI
    00885825017620
    PMA / PMN Number
    K133578
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS FOR EVALUATION. IT WAS STATED BY THE CUSTOMER FACILITY THE DEVICE IS NOT AVAILABLE FOR STRYKER TO INVESTIGATE AT THIS TIME. AS THE DEVICE WAS NOT RETURNED FOR EVALUATION, VISUAL AND FUNCTIONAL INSPECTION WAS UNABLE TO BE PERFORMED. A REVIEW OF THE DHR FOR THE REPORTED LOT NUMBER SUPPORTS THAT THE DEVICE MET ALL INSPECTION AND TEST CRITERIA PRIOR TO RELEASE FROM STRYKER. THE REPORTED EVENT COULD BE ATTRIBUTED TO: - GRASPING ON TOO MUCH TISSUE OR INAPPROPRIATE TISSUE TYPES OR ON STAPLES. TISSUE BUILD UP (ESCHAR). - DULL OR DAMAGED CUTTING BLADE. - MISHANDLING SUBSEQUENT TO DISTRIBUTION FROM STRYKER. THE INSTRUCTIONS FOR USE (IFU) STATE: - 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. 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. - 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. - 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 ATTEMPT TO SEAL OR CUT OVER CLIPS OR STAPLES AS INCOMPLETE SEALS WILL BE FORMED. - DO NOT APPLY ADDITIONAL HAND FORCE TO THE LEVER DURING SEALING TO ENSURE PROPER FUNCTION. - PRIOR TO CUTTING THE SEAL, INSPECT THE VESSEL OR TISSUE TO ENSURE PROPER SEALING. - OPEN THE JAWS BY SQUEEZING THE LEVER UNTIL IT UNLOCKS, THEN PUSH IT COMPLETELY FORWARD. - INSPECT THE INSTRUMENT JAWS PRIOR TO CLEANING TO ENSURE THE BLADE IS NOT DEPLOYED. - DO NOT ACTIVATE THE INSTRUMENT OR CUTTING TRIGGER WHILE CLEANING THE JAWS. INJURY TO OPERATING ROOM PERSONNEL MAY RESULT. - AVOID ACCIDENTAL ACTIVATION WHILE CLEANING THE INSTRUMENT BY PLACING LIGASURE MODE IN STANDBY. PRESS THE STANDBY BUTTON ON THE LIGASURE SCREEN TO BLOCK ENERGY DELIVERY. - KEEP THE INSTRUMENT JAWS CLEAN. BUILD-UP OF ESCHAR MAY REDUCE THE SEAL AND/OR CUTTING EFFECTIVENESS. WIPE JAW SURFACES AND EDGES WITH A WET GAUZE PAD AS NEEDED. - DO NOT ATTEMPT TO CLEAN THE INSTRUMENT JAWS BY ACTIVATION THE INSTRUMENT ON THE WET GAUZE. PRODUCT DAMAGE MAY OCCUR. - DO NOT CLEAN THE INSTRUMENT JAWS WITH A SCRATCH PAD OR OTHER ABRASIVES. SHOULD THE DEVICE BECOME AVAILABLE FOR RETURN, THE INVESTIGATION WILL BE REOPENED. THE REPORTED EVENT WILL CONTINUE TO BE MONITORED THROUGH POST-MARKET SURVEILLANCE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN TRIED TO USE THE LIGASURE DEVICE AND IT MALFUNCTIONED. THE DEVICE WOULD NOT CUT TISSUE AND CAUSED BLEEDING. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION INCLUDING VOLUME OF BLOOD LOSS AND PATIENT STATUS. NO INFORMATION WAS PROVIDED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117046 NA ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, R NUJ STRYKER SUSTAINABILITY SOLUTIONS LAKELAND LF1637 5063654 00885825017620

    Patients

    Seq Age Sex Outcome Treatment
    1