BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COVIDIEN MEDTRONIC STAPLER

    MDR report key: 8912205 · Received August 19, 2019

    Report

    Report Number
    MW5089177
    Event Type
    Injury
    Date Received
    August 19, 2019
    Date of Event
    September 28, 2018
    Report Date
    August 15, 2019
    Manufacturer
    MEDTRONIC / COVIDIEN
    Product Code
    GDW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    STAPLER MISFIRED AND THREE OTHER STAPLERS WERE ATTEMPTED. PT DEVELOPED AN SSI POST OP RECTAL CANCER SURGERY. ADD'L SURGERIES NEEDED, EXTENSIVE HOSP STAY. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698815 COVIDIEN MEDTRONIC STAPLER STAPLE, IMPLANTABLE GDW MEDTRONIC / COVIDIEN EGIAUSTND
    698816 COVIDIEN MEDTRONIC STAPLER STAPLE, IMPLANTABLE GDW MEDTRONIC / COVIDIEN EGIAUSTND
    698817 COVIDIEN MEDTRONIC STAPLER STAPLE, IMPLANTABLE GDW MEDTRONIC / COVIDIEN EGIAUSTND
    698818 COVIDIEN MEDTRONIC STAPLER STAPLE, IMPLANTABLE GDW MEDTRONIC / COVIDIEN EGIAUSTND

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| O| R| S