BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    MDR report key: 1221922 · Received November 4, 2008

    Report

    Report Number
    1219930-2008-00803
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    October 14, 2008
    Report Date
    October 14, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: ANTERIOR RESECTION. ACCORDING TO THE REPORTER: FOUR RELOADS WERE USED AND DID NOT FIRE A COMPLETE STAPLE LINE. THE LOADS WOULD NOT DETACH FROM TISSUE AND CAUSED A TEAR IN THE RECTUM. THE PT STATUS WAS REPORTED AS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA UNIVERSAL 12MM SINGLE USE INST NONE GDW NORTH HAVEN - USS N8F370

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention MFR DATE: 05/2008| ENDO GIA ROTICULATOR 45-3.5 SULU| LOT N8E141