BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TA 90 - 3.5 SINGLE USE RELOADABLE

    MDR report key: 2973506 · Received February 15, 2013

    Report

    Report Number
    2647580-2013-00088
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 18, 2013
    Manufacturer
    COVIDIEN, FORMERLY USSC
    Product Code
    GDW
    PMA / PMN Number
    YA9035S
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAPAROSCOPIC RT COLECTOMY. ACCORDING TO THE REPORTER: A LEAK OCCURRED AT THE SITE OF THE ENTEROTOMY ON A SIDE BY SIDE COLON FIVE DAYS POST OPERATION. AN EEA LINEAR STAPLER WAS USED TO CREATE THE ANASTOMOSIS. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69593 TA 90 - 3.5 SINGLE USE RELOADABLE DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY USSC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other