BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH** ETS45

    MDR report key: 3211385 · Received July 8, 2013

    Report

    Report Number
    3005075853-2013-03448
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    June 9, 2013
    Report Date
    June 13, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DAMAGED YOKE. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. THE ANALYSIS RESULTS FOUND THAT AN ETS45 DEVICE WAS RECEIVED WITH THE FIRING MECHANISM DAMAGED AND WITH NO CARTRIDGE RELOAD PRESENT. NO FUNCTIONAL TEST WAS PERFORMED DUE TO THE CONDITION OF THE DEVICE. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE YOKE WAS FOUND BROKEN WHERE IT GUIDES THE SHORT RACK. ALTHOUGH NO CONCLUSION COULD BE REACHED AS TO HOW THE YOKE BECAME BROKEN, 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 A LEFT NEPHRECTOMY PROCEDURE, THE SURGEON USED THE DEVICE TO TRANSECT THE RENAL ARTERY AND VEIN. MALFORMED STAPLES FOUND AND THE BLOOD WAS BLEEDING. THE SURGEON CHANGED THE PROCEDURE TO OPEN. 1000CC BLOOD TRANSFUSION WAS TAKEN, AND MORE ANESTHETIC WAS USED. THE PROCEDURE WAS PROLONGED ABOUT 20 MIN. AFTER THE PROCEDURE, THE PATIENT WAS SENT TO ICP FOR OBSERVATION ABOUT 12 HOURS, AND NOW THE PATIENT WAS FINE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310061 ENDOPATH** ETS45 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK J4AW46

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention