BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60

    MDR report key: 1970603 · Received August 23, 2010

    Report

    Report Number
    1970603
    Event Type
    Malfunction
    Date Received
    August 23, 2010
    Date of Event
    August 17, 2010
    Report Date
    August 23, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    STAPLER WITH NEW RELOAD FIRED FOR 5TH TIME DURING CASE. DEVICE CUT TISSUE BUT NO STAPLES WERE FIRED. THE ORANGE PINS ON DEVICE WERE DISCHARGED SHOWING THAT THE DEVICE FUNCTIONED PROPERLY.====================== HEALTH PROFESSIONAL'S IMPRESSION======================NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON 60 STAPLER, SURGICAL GDW ETHICON ENDO-SURGERY, LLC ECHELON FLEX60 G4TA7T
    2 ECHELON STAPLER, RELOAD, SURGICAL GDW ETHICON ENDO-SURGERY, LLC ECR60B G4TA6P (X3)

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR