BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOHNSON AND JOHNSON ECHELON FLEX 60 POWERED

    MDR report key: 2792479 · Received October 10, 2012

    Report

    Report Number
    MW5027237
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    October 9, 2012
    Report Date
    October 10, 2012
    Manufacturer
    ONE JOHNSON & JOHNSON PLAZA
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ARTICULATING ENDOSCOPIC LINEAR CUTTER ECHELON FLEX 60 POWERED MALFUNCTION DURING USE INSIDE A PT DURING A LAPAROSCOPIC ROBOTIC PROCEDURE. INSTRUMENT CLOSED ON TISSUE, RENAL VEIN. CUTTING AND STAPLING DEVICE UNABLE TO ENGAGE/ACTIVATE. INSTRUMENT NEEDED TO BE MANUALLY OPENED TO REMOVE FROM VEIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOHNSON AND JOHNSON ECHELON FLEX 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER ECHELON FLEX 60 GDW ONE JOHNSON & JOHNSON PLAZA PSE60A J4AY77

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention