BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** ETS

    MDR report key: 1972901 · Received January 28, 2011

    Report

    Report Number
    3005075853-2011-00339
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    December 16, 2010
    Report Date
    December 28, 2010
    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). THE ANALYSIS RESULTS FOUND THAT THE SCW45 DEVICE WAS RECEIVED WITH THE FIRING MECHANISM DAMAGED AND WITH A RELOAD LOADED IN THE DEVICE. THE RELOAD WAS RECEIVED FULLY LOADED WITH STAPLES. 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 REACHED AS TO WHAT CAUSED THE FIRING MECHANISM TO FAIL, IT IS POSSIBLE THAT THE DEVICE WAS FIRED ON TISSUE THICKER THAN INDICATED OR THROUGH A LOCKED CARTRIDGE IN PREVIOUS FIRINGS. WHEN EITHER OR BOTH OF THESE SCENARIOS OCCUR THE COMPONENTS IN THE FIRING MECHANISM CAN BE DAMAGED. IT SHOULD BE NOTED THAT A 100% INSPECTION TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS; (B)(4). A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE LOADED WITH THE ORIGINAL CARTRIDGE COULD BE FIRED PROPERLY AT THE FIRST FIRING BUT WHEN THE DEVICE WAS FIRED ON THE SECOND FIRING THE KNIFE DID NOT MOVE FORWARD AND THE STAPLES WERE NOT DEPLOYED AT ALL. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH** ETS STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK E4LR23

    Patients

    Seq Age Sex Outcome Treatment
    1