BEUDAMED
    FDA Adverse Event Other Summary report: N

    ETHICON ENDO-SURGERY, INC.

    MDR report key: 751437 · Received September 12, 2005

    Report

    Report Number
    MW1036565
    Event Type
    Other
    Date Received
    September 12, 2005
    Date of Event
    September 7, 2005
    Report Date
    September 9, 2005
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGEON USED THE LINEAR STAPLER ON THE UTERUS. THE FIRST FIRING OF THE STAPLER WAS GOOD. THE SECOND FIRING MISFIRED. WE OPENED NEW PACKAGE OF LINEAR STAPLER. SURGEON FIRED THE STAPLER. THE NEW STAPLER MISFIRED ALSO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDO-SURGERY, INC. ETS COMPACT FLEX45 ARTICULATING LINEAR CUTTER KOG ETHICON ENDO-SURGERY, INC. * V43G30

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other