BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAPLE, IMPLANTABLE

    MDR report key: 4802446 · Received May 28, 2015

    Report

    Report Number
    3005075853-2015-03260
    Event Type
    Malfunction
    Date Received
    May 28, 2015
    Date of Event
    April 7, 2015
    Report Date
    April 14, 2015
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TRIGGER TEETH. THE ANALYSIS RESULTS FOUND THAT THE ATS45NK DEVICE WAS RECEIVED WITH THE FIRING MECHANISM DAMAGED AND WITH NO CARTRIDGE RELOAD PRESENT. NO FURTHER FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE FIRING TRIGGER TEETH WERE FOUND BROKEN. WHILE NO CONCLUSION COULD BE REACHED ON WHAT CAUSED THE FIRING MECHANISM TO FAIL, IT IS POSSIBLE THAT THE DEVICE WAS ATTEMPTED TO FIRE ON THICKER TISSUE THEN INDICATED OR ATTEMPTED TO FIRE THROUGH A LOCKED RELOAD IN PREVIOUS FIRINGS CAUSING AN INCREASE OF THE INTERNAL FORCES RESULTING IN THE COMPONENT YIELDING. IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS; IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT (B)(4) .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC AORTOBIFEMORAL BYPASS PROCEDURE WITH DA VINCI ROBOT, NO STAPLE WAS RELEASED AND THE DEVICE REMAINED CLOSED ON TISSUES. THE AORTA WAS SQUASHED IN THE CLAMP FORTUNATELY NO CONSEQUENCES TO NOTE. THEN, THE SURGEON HAD DIFFICULTIES TO OPEN THE DEVICE. THE CARTRIDGE CONTAINED STAPLES WITHOUT A PARTICULAR PROBLEM. ANOTHER LIKE DEVICE (LOT L4F11A) WAS USED TO COMPLETE THE PROCEDURE AND NO INCIDENT REPORTED. NO CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346263 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK K4CF46

    Patients

    Seq Age Sex Outcome Treatment
    1