BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON*FLEX45 COMPACT

    MDR report key: 2222549 · Received August 25, 2011

    Report

    Report Number
    3005075853-2011-03497
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 18, 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
    KY, US
    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 THE DEVICE WAS USED DURING A VATS LOBECTOMY. THE DEVICE WAS FIRED ON THE BRANCH OF THE PULMONARY ARTERY AND THERE WAS STAPLE LINE OOZING. THE SURGEON THEN FIRED ON THE PULMONARY ARTERY AND THE STAPLES WERE "B" FORMED AS INTENDED, HOWEVER THERE WAS EXCESSIVE BLEEDING COMING FROM THE STAPLE LINE. THE PATIENT'S BLOOD LOSS WAS 600CC, BLOOD AND/OR BLOOD PRODUCT WAS PULLED BUT IT IS UNKNOWN IF THEY WERE REQUIRED. THE PROCEDURE WAS CONVERTED TO AN OPEN PROCEDURE. THE BLEEDING WAS CONTROLLED BY TRADITIONAL OPEN METHODS. THE PATIENT IS DOING FINE. THE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX45 COMPACT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

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