BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIA 60-3.8 SINGLE USE LOADING UNIT

    MDR report key: 3170367 · Received June 7, 2013

    Report

    Report Number
    2647580-2013-00307
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    May 15, 2013
    Manufacturer
    COVIDIEN, FORMERLY USSC
    Product Code
    GDW
    PMA / PMN Number
    GIA6038L
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: COLECTOMY. ACCORDING TO THE REPORTER: ON THE 3RD FIRING OF GIA (CREATING ANASTOMOSIS), THE TISSUE TORE AND THE STAPLES MALFORMED. THE SURGEON HAD TO RESECT AND START OVER AGAIN. LUCKILY, HE HAD ENOUGH COLON LEFT TO CREATE ANOTHER ANASTOMOSIS. THE CASE WAS EXTENDED BY MORE THAN 30 MINUTES. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 250CC. THERE WAS NO USER INVOLVEMENT OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253499 GIA 60-3.8 SINGLE USE LOADING UNIT DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY USSC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other