BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON ENDOPATH ETS-FLEX 45

    MDR report key: 1904261 · Received November 15, 2010

    Report

    Report Number
    MW5018235
    Event Type
    Injury
    Date Received
    November 15, 2010
    Date of Event
    August 25, 2010
    Report Date
    November 15, 2010
    Manufacturer
    ETHICON
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ETHICON STAPLER 45 MM WAS BEING USED IN A THORACIC SURGICAL CASE. THE VASCULAR STAPLER WAS ABLE TO BE FIRED AFTER BEING LOADED, IN ERROR, WITH A 35MM STAPLER CARTRIDGE. THE EVENT LEAD TO SIGNIFICANT PT BLOOD LOSS BUT THE PT REMAINED STABLE DUE TO RESUSCITATION EFFORTS. WOULD EXPECT THAT THE DESIGN OF THE STAPLER WOULD NOT ALLOW FIRING IF LOADED WITH INCORRECT STAPLE SIZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDOPATH ETS-FLEX 45 STAPLER GDW ETHICON ATS 45

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| S