BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EGIA 60 ARTICULATING XTRA THICK SULU

    MDR report key: 3131385 · Received May 13, 2013

    Report

    Report Number
    1219930-2013-00368
    Event Type
    Injury
    Date Received
    May 13, 2013
    Date of Event
    March 20, 2013
    Report Date
    April 16, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K093410
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: SLEEVE GASTRECTOMY. ACCORDING TO THE REPORTER: SURGEON WAS PERFORMING THIRD FIRING OF SLEEVE GASTRECTOMY. NO REINFORCEMENT MATERIAL USED. TISSUE CRUMPLED UP IN THE JAWS OF ENDO GIA AND IT WAS VERY DIFFICULT TO RELEASE THE JAWS FROM THE TISSUE. STAPLES DID NOT FORM CORRECTLY AND SEROSAL TISSUE WAS TORN. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THE SURGEON HAD ENOUGH ROOM TO MAKE ANOTHER STAPLE LINE BETWEEN THE EXISTING STAPLE LINE AND THE BOUGIE. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211614 EGIA 60 ARTICULATING XTRA THICK SULU DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY US SURGICAL N2M0467UX

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention