BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLUE RELOAD FOR ECHELON 60

    MDR report key: 1210150 · Received October 20, 2008

    Report

    Report Number
    3005075853-2008-02470
    Event Type
    Malfunction
    Date Received
    October 20, 2008
    Date of Event
    September 25, 2008
    Report Date
    September 26, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL GASTRECTOMY PROCEDURE, A PART OF THE STAPLE WAS MALFORMED. ADDITIONAL SUTURING AND ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLUE RELOAD FOR ECHELON 60 GDW ETHICON ENDO-SURGERY, LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1