BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    MDR report key: 2210027 · Received August 2, 2011

    Report

    Report Number
    1219930-2011-00637
    Event Type
    Injury
    Date Received
    August 2, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 20, 2011
    Manufacturer
    UNITED STATES SURGICAL A
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: PNEUMONECTOMY. ACCORDING TO THE REPORTER: UPON FIRING THE DEVICE, THE HANDLE CRACKED. THE SURGEON THEN REMOVED IT FROM THE FIELD. THE ORIGINAL HANDLE WAS LOADED AGAIN WITH A NEW LOAD AND THE CASE WAS COMPLETED. A LEAK TEST WAS DONE AND EVERYTHING LOOKED AND TESTED FINE. ON (B)(6) 2011 PATIENT RETURNED TO THE HOSPITAL WITH COMPLICATIONS. RE-OPERATION OCCURRED ON (B)(6) 2011 AND SURGEON FOUND THAT THE MIDDLE PORTION OF THE STAPLE LINE WAS SLIGHTLY OPENED. THE SURGEON SUTURED THE STAPLE LINE. THE PATIENT IS STILL HOSPITALIZED IN VERY POOR CONDITION. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 250CC. OPERATIVE TIME WAS NOT EXTENDED BY MORE THAN 30 MINUTES. THERE WAS NO TISSUE DAMAGE OR UNANTICIPATED TISSUE LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA UNIVERSAL 12MM SINGLE USE INST DISPOSABLE SURGICAL STAPLING DEVICE GDW UNITED STATES SURGICAL A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EGIA 60 ARTICULATING MED/THICK SULU:| CATALOG #: EGIA60AMT, (B)(4)