BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETS FLEX

    MDR report key: 1843906 · Received September 24, 2010

    Report

    Report Number
    3005075853-2010-05488
    Event Type
    Injury
    Date Received
    September 24, 2010
    Date of Event
    August 27, 2010
    Report Date
    September 2, 2010
    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
    MA, 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 DURING A LOBECTOMY PROCEDURE, THE STAFF PLACED A 35MM WHITE LOAD INTO THE 45 DEVICE. THE DEVICE WAS FIRED ACROSS THE PULMONARY VESSEL AND THE DEVICE CUT AND DID NOT STAPLE. THE BLOOD BANK WAS CALLED FOR UNITS OF BLOOD AND A VASCULAR SURGEON HAD TO BE CALLED IN TO REPAIR THE VESSEL. THE AMOUNT OF BLOOD LOSS AND THE AMOUNT OF UNITS ARE UNKNOWN. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED. THE DEVICE WAS DISCARDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention RELOAD-TR35W