BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIA 60-3.8 SINGLE US RELOADABLE STAPLER

    MDR report key: 4071288 · Received September 5, 2014

    Report

    Report Number
    2647580-2014-00738
    Event Type
    Injury
    Date Received
    September 5, 2014
    Report Date
    August 12, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO, INC.
    Product Code
    GDW
    PMA / PMN Number
    K013860
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: COLECTOMY. ACCORDING TO THE REPORTER: DURING THE PROCEDURE, NO ISSUES WERE NOTED. NO REINFORCEMENT MATERIAL WAS USED DURING THE CASE. POSSIBLY ON POSTOP DAY 2 OR 3, THE PT EXHIBITED A BLEED AT THE ANASTOMOSIS. THERE IS A POTENTIAL THE PT WENT BACK TO THE OPERATING ROOM. CURRENT STATUS OF PT IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543572 GIA 60-3.8 SINGLE US RELOADABLE STAPLER DISPOSABLE SURGICAL STAPLER GDW COVIDIEN, FORMERLY USSC PUERTO RICO, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GIA 80-3.8 SINGLE USE LOADING UNIT, GIA8038L,| (B)(4)