BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA ROTICULATOR 60-3.5 SULU

    MDR report key: 1253380 · Received December 2, 2008

    Report

    Report Number
    1219930-2008-00870
    Event Type
    Injury
    Date Received
    December 2, 2008
    Date of Event
    November 21, 2008
    Report Date
    November 26, 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: LUNG RESECTION. ACCORDING TO THE REPORTER: THE INSTRUMENT STOPPED FIRING AT HALF WAY. IT WAS REMOVED FROM TISSUE BY FORCE AND NEW CARTRIDGE WAS FIRED. HOWEVER, THE SAME THING OCCURRED. IT WAS NOTED THAT THE ANVILS WERE BENT. ADDITIONAL TISSUE WAS RESECTED TO TREAT THE PROBLEM. EXTENDED OR TIME WAS REPORTED AS WITHIN 30 MIN. PATIENT STATUS REPORTED AS UNDER OBSERVATION, NO OTHER PATIENT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA ROTICULATOR 60-3.5 SULU DISPOSABLE STAPLER GDW NORTH HAVEN - USS N8K213

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability