BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA II 45-3.5 DLU

    MDR report key: 2170061 · Received July 13, 2011

    Report

    Report Number
    2647580-2011-00461
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    February 3, 2011
    Report Date
    July 4, 2011
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE RPTR: THE PHYSICIAN STATED THAT THE SULU WAS WITH DEFECT. THE STAPLER LOCKED IN THE MIDDLE OF FIRING. THERE WAS POOR STAPLE FORMATION DUE TO THIS ISSUE. BLEEDING IN EXCESS OF 250CC WAS REPORTED. OPERATIVE TIME WAS NOT EXTENDED BY MORE THAN 30 MINUTES. THERE WAS NO UNANTICIPATED TISSUE DAMAGE. NO ADDITIONAL SURGICAL PROCESS WAS NECESSARY TO CORRECT THE STAPLER PROBLEM. NO INJURY TO THE PT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA II 45-3.5 DLU DISPOSABLE STAPLER GDW USSC PUERTO RICO P0H0179

    Patients

    Seq Age Sex Outcome Treatment
    1 Other