BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EGIA 45 ARTICULATING MED/THICK SULU

    MDR report key: 5935865 · Received September 8, 2016

    Report

    Report Number
    1219930-2016-00946
    Event Type
    Injury
    Date Received
    September 8, 2016
    Date of Event
    August 17, 2016
    Report Date
    August 19, 2016
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    GDW
    PMA / PMN Number
    K083519
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    FTR# (B)(4). POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. VISUAL EXAMINATION OF THE STAPLE CARTRIDGE NOTED THAT THE RELOAD WAS PARTIALLY FIRED TO THE 0.5 CM CUT LINE. THERE WERE NO PROTRUDING STAPLES OR VISIBLE PUSHERS PAST THE 0.5 CM CUT LINE AT THE DISTAL END OF THE CARTRIDGE. FUNCTIONAL TESTING WAS SATISFACTORY. DURING FUNCTIONAL TESTING, IT WAS DETERMINED THAT ALL STAPLES WERE DEPLOYED DURING THE ORIGINAL FIRING BUT THE SLED WAS NOT FULLY ADVANCED. CONCURRENTLY WITH ENGINEERING, A TEST RELOAD WAS FIRED ONTO TEST MEDIA AND HANDLE COMPRESSION WAS STOPPED AT THE 0.5 CM CUT LINE TO REPLICATE HOW THE DEVICE WAS RECEIVED. IT WAS NOTED THAT THE LAST SET OF STAPLES WERE PUSHED UP ENOUGH TO LATCH ONTO TISSUE AND BE PULLED OUT OF THE CARTRIDGE WITHOUT BEING FORMED. THE ROOT CAUSE WAS DETERMINED TO BE A MISUSE OF THE PRODUCT. THE TRI-STAPLE RELOAD OPERATES BY STAPLING AHEAD OF THE KNIFE-BAR. A SLED PRECEDES THE KNIFE BLADE AND FORCES STAPLES OUT OF THE CARTRIDGE AND INTO THE ANVIL TO BE FORMED. THEREFORE, STAPLES ARE PLACED INTO TISSUE BEFORE IT IS CUT TO MINIMIZE BLEEDING. INCOMPLETE HANDLE COMPRESSION CAN CAUSE STAPLES TO PROTRUDE FROM THE CARTRIDGE AHEAD OF THE SLED AND LATCH ONTO TISSUE TO BE PULLED OUT WITHOUT BEING PROPERLY FORMED. THE HANDLE MUST BE COMPRESSED UNTIL THE KNIFE-BAR FULLY REACHES THE DISTAL END OF THE RELOAD TO ENSURE ALL STAPLES ARE PROPERLY DEPLOYED.THE PRODUCT ANALYSIS ESTABLISHED A RELATIONSHIP BETWEEN A DEVICE FAILURE AND THE REPORTED INCIDENT OF JAWS WILL NOT OPEN. NO ENHANCEMENTS OR IMPROVEMENTS WERE GENERATED FOR THE REPORTED CONDITION. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY WILL BE AMENDED AS APPROPRIATE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, UPON THE FIRST FIRING TO CLOSE AN INCISION OF THE DELTA-SHAPED ANASTOMOSES DURING A LAPAROSCOPIC ASSISTED DISTAL GASTRECTOMY, THE SURGEON SQUEEZED THE HANDLE TO THE END AND PULLED BACK THE BLACK RETURN KNOB. THE STAPLES AT THE TIP OF THE RELOAD WERE NOT FORMED CORRECTLY. THE UNFORMED STAPLES FELL FROM THE RELOAD AND A PART OF THE TISSUE WAS NOT SUTURED, WHICH WAS COMPLETED MANUALLY. IT WAS ALSO REPORTED THAT THE TISSUE WAS NOT THICK. THE STAPLES WERE REMOVED FROM THE PATIENT CAVITY SUCCESSFULLY AND THERE WAS NO INJURY TO THE PATIENT. NO BUTTRESS MATERIAL WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588025 EGIA 45 ARTICULATING MED/THICK SULU STAPLE, IMPLANTABLE GDW COVIDIEN, FORMERLY US SURGICAL A DIVISON EGIA45AMT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EGIA ULTRA UNIVERSAL STAPLER