BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** ETS COMPACT

    MDR report key: 2211344 · Received August 15, 2011

    Report

    Report Number
    3005075853-2011-03291
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 12, 2011
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4): FIRING TRIGGER TEETH. THE ANALYSIS RESULTS FOUND THAT THE SCW45 DEVICE WAS RECEIVED WITH THE FIRING MECHANISM DAMAGED AS THE KNIFE WAS EXPOSED, AND WITH FIVE RELOADS PRESENT. RELOADS D AND F WERE RECEIVED FULLY FIRED; RELOADS B, C, AND E WERE RECEIVED PARTIALLY FIRED AND WITH THE LOCKOUT SPRING NORMAL. NO 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 REACH ON WHAT CAUSE THE FIRING MECHANISM TO FAIL, IT IS POSSIBLE THAT THE DEVICE WAS ATTEMPTED TO FIRE ON TICKER TISSUE THEN INDICATED OR ATTEMPTED TO FIRE TROUGH 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 AN OPEN LOBECTOMY PROCEDURE, THE DEVICE COULD BE FIRED ON THE PULMONARY VEIN PROPERLY TILL THE 2ND FIRING. HOWEVER, THE STAPLES OF THE ACRAL PART (ABOUT 1/3) WERE NOT DEPLOYED AT THE 3RD TO 5TH FIRING. REINFORCEMENT MATERIAL WAS NOT USED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH** ETS COMPACT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK F4NP9U

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4)