BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON FLEX60

    MDR report key: 1960025 · Received December 30, 2010

    Report

    Report Number
    1960025
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    July 28, 2010
    Report Date
    December 30, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US

    Narratives

    Description of Event or Problem · 1

    PATIENT IN FOR LAPAROSCOPIC RESECTION OF GASTRIC CANCER AND LYMPH NODES BIOPSY WITH FROZEN SECTION. THE ETHICON STAPLER, ECHELON FLEX 60, EC60A DEVICE MISFIRED AND WAS REMOVED FROM SURGICAL FIELD. NO HARM TO PATIENT. ANOTHER STAPLER WAS OPENED AND USED FOR PROCEDURE WITHOUT INCIDENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON FLEX60 STAPLER, SURGICAL GDW ETHICON ENDO-SURGERY, INC. EC60A G4RT7U

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR