BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON 60

    MDR report key: 2211396 · Received August 15, 2011

    Report

    Report Number
    3005075853-2011-03292
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 22, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN RIGHT LOWER LOBECTOMY, THE BLUE LOAD WAS USED ON THE LUNG PARENCHYMA AT THE FIRST FIRING AFTER THE BLOOD VESSEL WAS TREATED. AT THE FIRST STROKE OF THE FIRST FIRING, BLEEDING OCCURRED. THE AMOUNT OF BLEEDING WAS ABOUT 4000CC. BLOOD TRANSFUSION WAS PERFORMED, BUT THE AMOUNT WAS UNKNOWN. THE FORMATION OF THE DEPLOYED STAPLES COULD NOT BE CONFIRMED DUE TO THE BLEEDING. REINFORCEMENT MATERIAL WAS NOT USED. ADDITIONAL SUTURE WAS PERFORMED. NO DEVICE WILL BE RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON 60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention