BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIA 80-3.8 SINGLE USE RELOADABLE STAPLER

    MDR report key: 3855004 · Received May 28, 2014

    Report

    Report Number
    2647580-2014-00390
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    April 17, 2014
    Report Date
    May 7, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: ESOPHAGOGASTRECTOMY. ACCORDING TO THE REPORTER: UPON TRYING TO CLOSE THE OPENING TO INSERT THE DEVICE AFTER ANASTOMOSIS, A DOCTOR FOUND THE DEVICE STOPPED FIRING IN THE MIDDLE AND COULD NOT FULLY SQUEEZE THE FIRING KNOB. LATER HE CONFIRMED IT COULD BE THE THUMB PIECE COULD NOT BE PULLED BACK. A NEW INSTRUMENT WAS OPENED TO COMPLETE THE CASE WITH NO PROBLEM. THERE WAS, HOWEVER, ADDITIONAL TISSUE RESECTED. NO EXTENSION IN OPERATING TIME EXTENDED. NOTHING FELL INTO THE CAVITY. NO BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314821 GIA 80-3.8 SINGLE USE RELOADABLE STAPLER DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY USSC PUERTO RICO, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other