BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIA 60 - 3.8 SINGLE USE RELOADABLE STAPLER

    MDR report key: 3800313 · Received May 2, 2014

    Report

    Report Number
    2647580-2014-00329
    Event Type
    Injury
    Date Received
    May 2, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 9, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO
    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

    ACCORDING TO THE REPORTER: NO PROBLEM TO FINISH THE THIRD FIRING. AT THE 4TH FIRING THE FIRING KNOB STOPPED IN THE MIDDLE OF FIRING. UNLOCKED AND RELEASE IT FROM TISSUE NORMALLY. CONFIRMED MALFORMATION OF STAPLES ON TISSUE IN SOME PART AND RETRIEVED THEM FROM PATIENT BY USE OF FORCEPS. BY SUTURING THE CASE WAS COMPLETED. NO PATIENT HARM. PATIENT CURRENT STATUS IS GOOD. OPERATING TIME NOT EXTENDED. REPORTED THE 4TH FIRING WAS DONE ON THE AREA BY AVOIDING THE PART OF THICKENED TISSUE. ADDITIONAL TISSUE RESECTION: YES. TISSUE DAMAGE: YES. PIECES FELL INTO THE CAVITY AND COULD BE RETRIEVED. OOZING BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264247 GIA 60 - 3.8 SINGLE USE RELOADABLE STAPLER DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY USSC PUERTO RICO

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other