BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIA 80-3.8 SINGLE USE RELOADABLE STAPLER

    MDR report key: 2973507 · Received February 15, 2013

    Report

    Report Number
    2647580-2013-00087
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 18, 2013
    Manufacturer
    COVIDIEN, FORMERLY USSC
    Product Code
    GAG
    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: ESOPHAGECTOMY/GASTRIC TUBE. ACCORDING TO THE REPORTER: THE STAPLES WERE MALFORMED AT THE THIRD FIRING FOR MAKING A GASTRIC TUBE. THE SURGEON STATES, THE STAPLES STARTED TO BE MALFORMED AS FIRING PROGRESSED AND WERE SCATTERED. THE FALLEN STAPLES WERE RETRIEVED FROM THE CAVITY AND A NEW DEVICE WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS OOZING AND UNANTICIPATED TISSUE LOSS. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. NO REINFORCEMENT MATERIAL USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69521 GIA 80-3.8 SINGLE USE RELOADABLE STAPLER DISPOSABLE SURGICAL STAPLING DEVICE GAG COVIDIEN, FORMERLY USSC P2J0345X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other GIA 80-3.8 SINGLE USE LOADING UNIT| LOT# P2J0330X, MAN. 09/12, EXP. 09/30/2017| (B)(4)