BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    MDR report key: 1060421 · Received June 12, 2008

    Report

    Report Number
    1219930-2008-00447
    Event Type
    Injury
    Date Received
    June 12, 2008
    Date of Event
    June 5, 2008
    Report Date
    June 6, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: WEDGE RESECTION. ACCORDING TO THE REPORTER: ON THE THIRD FIRING 45-3.5 WERE FIRED AND THE SPECIMEN WAS RETRIEVED. THEN, THE SURGEON FOUND UNFORMED STAPLES WITH STRAIGHT LEGS ON THE RESECTED TISSUE. LEAK WAS FOUND AT THE LEAK TEST. THE SURGEON EXTENDED THE INCISION AND OVER SEWED THE STAPLE LINE TO REINFORCE. OOZING BLEEDING WAS REPORTED. PT STATUS REPORTED AS UNDER OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA UNIVERSAL 12MM SINGLE USE INST DISPOSABLE STAPLING DEVICE GDW NORTH HAVEN - USS N8A307

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention MANUFACTURE DATE: 02/01/2008| 030455| LOT N8B431| ENDO GIA ROTICULATOR 45-3.5 SULU| EXPIRATION DATE: 02/28/2013