BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 2494626 · Received March 16, 2012

    Report

    Report Number
    1056128-2012-00025
    Event Type
    Malfunction
    Date Received
    March 16, 2012
    Date of Event
    February 21, 2012
    Report Date
    February 22, 2012
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS
    Product Code
    NUJ
    PMA / PMN Number
    K111600
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS (SSS) FOR AN EVALUATION. THE COMPLAINT DEVICE PASSED ALL FUNCTION TESTING. POTENTIAL CAUSES FOR THE REPORTED ISSUE CAN BE ATTRIBUTED (BUT NOT LIMITED) TO END USER TECHNIQUE, ESCHAR BUILD-UP ON THE JAWS AND IN THE BLADE GUIDING SLOTS AS THIS CAN AFFECT THE SEALING AND CUTTING EFFECTIVENESS, OR GRASPING MORE TISSUE THAN INTENDED BETWEEN THE JAWS. STRYKER SUSTAINABILITY SOLUTIONS' INSTRUCTION FOR USE STATE: "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." "PLACE THE VESSEL OR TISSUE IN THE CENTER OF THE JAWS. AVOID INCOMPLETE VESSEL SEALING BY NOT GRASPING TISSUE BEYOND THE ELECTRODE SURFACE OR PLACING IT IN THE JAW HINGE." "DO NOT ACTIVATE THE LIGASURE SYSTEM IN THE VESSEL SEALING MODE UNTIL THE VESSEL SEALING INSTRUMENT HAS BEEN APPLIED WITH THE PROPER PRESSURE. ACTIVATING THE SYSTEM BEFORE THIS IS DONE MAY RESULT IN IMPROPER SEAL AND MAY INCREASE THERMAL SPREAD TO TISSUE OUTSIDE SURGICAL SITE." "THE USER MUST SELECT THE APPROPRIATE BAR SETTING TO ACHIEVE THE DESIRED TISSUE EFFECT." A REVIEW OF THE LOT CONTROL SHEET FOR THE REPORTED DEVICE SERIAL NUMBER INDICATED THE DEVICE PASSED ALL INSPECTIONS PRIOR TO RELEASE FROM SSS. 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 DEVICE WAS "NOT RELIABLY SEALING VESSELS" AND IT IS BELIEVED THAT THE VESSEL WAS "HAND-SOWN." NO PATIENT INJURY WAS REPORTED BY THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A NUJ NUJ STRYKER SUSTAINABILITY SOLUTIONS LF4200 1796081

    Patients

    Seq Age Sex Outcome Treatment
    1