BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILS 29MM, CURVED

    MDR report key: 1904799 · Received November 22, 2010

    Report

    Report Number
    3005075853-2010-06598
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    October 27, 2010
    Report Date
    November 1, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE USE OF THE DEVICE DURING A LOW ANTERIOR RESECTION PROCEDURE, THE ANASTOMOSIS FAILED THE AIR LEAK TEST. THE PATIENT WAS GIVEN A TEMPORARY ILEOSTOMY. THE PATIENT WAS REPORTED TO BE STABLE FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ILS 29MM, CURVED STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. G4TA68

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R