BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIA 80-3.8 SINGLE USE RELOADABLE STAPLER

    MDR report key: 3131377 · Received May 13, 2013

    Report

    Report Number
    2647580-2013-00261
    Event Type
    Injury
    Date Received
    May 13, 2013
    Date of Event
    March 6, 2013
    Report Date
    April 18, 2013
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K013860
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: EXTENDED RT HEMICOLECTOMY DISTAL PANCREATECTOMY SPLENECTOMY. ACCORDING TO THE REPORTER: THE CUSTOMER REPORTS THAT ALL THE INSTRUMENTS FIRED WELL DURING THE PROCEDURE ON (B)(6) 2013. THE SIDE TO SIDE ANASTOMOSIS WAS SEWN. THE PT WAS DOING WELL UNTIL (B)(6) 2013. THE JP DRAIN BEGAN TO DRAIN THE STOOL CONSISTENT WITH THE DIAGNOSIS OF AN ANASTOMOTIC LEAK. ON (B)(6) 2013, A RESECTION OF ANASTOMOSIS AND AN ILEOSTOMY WAS PERFORMED. NOTHING FELL INTO THE PT'S CAVITY. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THERE WAS NO UNANTICIPATED TISSUE DAMAGE OR TISSUE LOSS AS A RESULT OF THIS PROBLEM. NO EXTENSION OF SURGICAL TIME WAS REQUIRED. THE CURRENT PT STATUS BEEN REPORTED AS RECOVERED. THE DEVICE IS NOT BEING RETURNED FOR EVAL AS IT WAS DISCARDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212149 GIA 80-3.8 SINGLE USE RELOADABLE STAPLER DISPOSABLE SURGICAL STAPLER GDW COVIDIEN, FORMERLY USSC PUERTO RICO P2H0741X

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other EXP DATE: 08/31/2017, #K013860| GIA 80-3.8 SINGLE USE LOADING UNIT: GIA8038L,| LOT# P2J0600X, MFG DATE: 08/2012,