BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA ROTICULATOR 30-2.5 SULU

    MDR report key: 1871978 · Received October 8, 2010

    Report

    Report Number
    1219930-2010-00786
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    September 29, 2010
    Report Date
    September 29, 2010
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT SENT TO FDA ON (B)(4) 2010.

    Description of Event or Problem · 1

    PROCEDURE: PNEUMONECTOMY. ACCORDING TO THE REPORTER: THE SULU CLOSED, BUT DID NOT CUT AND THE INSTRUMENT COULD NOT BE OPENED ANYMORE. THEN THE VESSEL WAS DISCONNECTED AND THE VESSEL WAS HAND SUTURED. SURGERY TIME EXTENSION WAS REPORTED AS MORE THAN MINUTES. THE PROCEDURE WAS CONVERTED TO OPEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA ROTICULATOR 30-2.5 SULU DISPOSABLE STAPLER GDW UNITED STATES SURGICAL N0A0183

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability ENDO GIA UNIVERSAL 12MM SINGLE USE INST| LOT NUMBER: N0F0443| EXP DATE: 06/30/2015, MANUFACTURE DATE: 06/2010| (B)(4)