BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS FLEX

    MDR report key: 2062503 · Received April 18, 2011

    Report

    Report Number
    2062503
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 14, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NH, US

    Narratives

    Description of Event or Problem · 1

    DURING A ROBOTIC ASSISTED RADICAL NEPHRECTOMY A PHYSICIAN ASSISTANT UNDER THE DIRECTION OF A SURGEON ATTEMPTED TO STAPLE A COLLATERAL VEIN WITH THE ETHICON ATS45 ARTICULATING ENDOSCOPIC LINEAR CUTTER. THE CUTTER CLOSED BUT WOULD NOT FIRE THE STAPLE. THE DEVICE AND PACKAGING WERE TAKEN OFF THE STERILE FIELD AND GIVEN TO OR MANAGER. A SECOND DEVICE WAS OPENED AND USED WITHOUT INCIDENT.MANUFACTURER RESPONSE FOR STAPLER, CUTTER, SURGICAL, ETS FLEX: HOSPITAL REPRESENTATIVE FOR ETHICON HAS PICKED UP DEVICE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS FLEX STAPLER, CUTTER, SURGICAL GDW ETHICON ENDO-SURGERY, INC. ATS45 H43870

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR