BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 31MM SINGLE-USE STAPLER

    MDR report key: 3981509 · Received July 25, 2014

    Report

    Report Number
    2647580-2014-00582
    Event Type
    Injury
    Date Received
    July 25, 2014
    Report Date
    July 3, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: HARTMAN PROCEDURE. ACCORDING TO THE REPORTER: WHEN RETRIEVING THE STAPLER, THEY REALIZED THAT THE STAPLER CUT BUT DID NOT STAPLE. THE STAPLES REMAINED UNFORMED ON TISSUE. THEY HAD TO RESECT THE AREA IN ORDER TO REMOVE THE STAPLES AND PERFORM A NEW TOBACCO-POUCH SUTURE. THEY PROCEEDED TO INTRODUCE ANOTHER DEVICE IN ORDER TO SOLVE THE ISSUE WITH THE PREVIOUS ONE. THIS TIME THE STAPLE LEFT A QUARTER OF THE DONUT OPENED WITH MALFORMED STAPLES. THEY REPEATED THE PROCESS OF RESECTING THE AREA, CLEANING THE STAPLES, CREATING A NEW TOBACCO-POUCH SUTURE, AND INTRODUCE ANOTHER DEVICE. THERE WAS NO BLEEDING OF MORE THAN 500CC BLEEDING. THERE WAS NO EXTENSION OF OPERATING TIME OF MORE THAN 30 MINUTES. THERE WAS UNANTICIPATED TISSUE LOSS. THERE WAS UNANTICIPATED TISSUE DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436763 EEA 31MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLER GDW COVIDIEN, FORMERLY USSC P3F0193X

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other