BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA II 45-4.8 SULU

    MDR report key: 2070334 · Received April 18, 2011

    Report

    Report Number
    2647580-2011-00257
    Event Type
    Injury
    Date Received
    April 18, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 13, 2011
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: THORACOTOMY. ACCORDING TO THE REPORTER: THE INSTRUMENT CLOSES NORMALLY BUT DID NOT FIRE COMPLETELY. THE PROCEDURE WAS COMPLETED WITH ELECTRO-CAUTERY. AS SOON AS THE SURGERY WAS COMPLETED BY MEANS OF THORAX RADIOGRAPHY INTRATHORAXIC DETECTS STRANGE BODY IN THE PT CORRESPONDING TO ONE OF THE GREEN CHARGES ENDOGIA. RE-OPERATION WAS NEEDED ON THE PT DETECTING ANOTHER SMALLER ADD'L STRANGE BODY TO HIM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA II 45-4.8 SULU DISPOSABLE STAPLER GDW USSC PUERTO RICO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R