BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIA 100-3.8 SINGLE USE RELOADABLE

    MDR report key: 3964913 · Received July 19, 2014

    Report

    Report Number
    2647580-2014-00443
    Event Type
    Injury
    Date Received
    July 19, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 21, 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
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: COLORECTAL. ACCORDING TO THE REPORTER: WHEN USING THE STAPLER GIA10038S WITH RELOAD GIA10038L DURING THE PROCEDURE WHEN PLACING AND CLOSING THE STAPLER ON THE COLON THE SURGEON FIRED THE STAPLER BUT ONLY THE KNIFE WORKED AND THE STAPLER DIDN'T PLACE THE STAPLES. BECAUSE OF THIS THE SURGEON HAD TO SUTURE BY HAND TO SAVE THE SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423989 GIA 100-3.8 SINGLE USE RELOADABLE DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY USSC PUERTO RICO, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other GIA 100-3.8 SINGLE USE LOADING UNIT MFG: 07/2012| GIA10038L LOT #: P2G0520X EXP: 07/31/2017