BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON 60 ENDOPATH STAPLER

    MDR report key: 1071388 · Received July 8, 2008

    Report

    Report Number
    3005075853-2008-00308
    Event Type
    Injury
    Date Received
    July 8, 2008
    Date of Event
    June 9, 2008
    Report Date
    June 10, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE ANALYSIS RESULTS FOUND THAT ONE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH NO CARTRIDGE LOADED ON THE DEVICE. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST CARTRIDGE AND IT ACHIEVED A COMPLETE 3-STROKES FIRE WITHOUT ANY DIFFICULTIES NOTED. THE DEVICE FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. EVENT DESCRIPTION COULD NOT BE CONFIRMED AS THE DEVICE FIRED AS INTENDED AND NO CARTRIDGE WAS RETURNED FOR ANALYSIS. WE HAVE DOCUMENTED THE CIRCUMSTANCES AS THEY WERE REPORTED TO US. IN ADDITION, COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. 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 A ROBOTIC LOBECTOMY, ON THE THIRD FIRING, THE DEVICE FULLY CUT BUT DELIVERED A PARTIAL STAPLE LINE. SEAM GUARD WAS NOT BEING USED. THERE WAS EXCESSIVE BLEEDING AND THEY HAD TO CONVERT TO AN OPEN THORACOTOMY TO CONTROL THE SITUATION. THE PT RECEIVED FOUR UNITS OF BLOOD AND WAS SENT TO THE ICU. THE PT'S HOSPITAL STAY WAS EXTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON 60 ENDOPATH STAPLER GDW ETHICON ENDO-SURGERY, LLC NA E4L337

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention