BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIA 60-3.8 SINGLE USE RELOADABLE STAPLER

    MDR report key: 1233971 · Received November 14, 2008

    Report

    Report Number
    2647580-2008-00642
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    October 21, 2008
    Report Date
    October 22, 2008
    Manufacturer
    PONCE - USS
    Product Code
    GDW
    PMA / PMN Number
    K013860
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: ILEUS SURGERY, COLECTOMY, FUNCTIONAL END TO END ANASTOMOSIS. ACCORDING TO THE REPORTER: THE DEVICE WAS FIRED ONTO THE SMALL INTESTINE. BOWEL CONTENT AND BLOOD LEAKED FROM NEAR THE STAPLE LINE. DR GRASPED THE TISSUE BY FORCEPS, AND THEN PERFORMED END TO END ANASTOMOSIS. SECOND FIRING OF DEVICE WAS SUCCESSFUL. THIS WAS AN EMERGENCY OPERATION FROM A VASCULAR SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GIA 60-3.8 SINGLE USE RELOADABLE STAPLER DISPOSABLE SURGICAL STAPLER GDW PONCE - USS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R GIA: 60-3.8 SINGLE USE LOADING UNIT: CATALOG #| LOT # UNK