BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON 60 ENDOPATH STAPLER

    MDR report key: 1020430 · Received February 29, 2008

    Report

    Report Number
    1527736-2008-01282
    Event Type
    Injury
    Date Received
    February 29, 2008
    Report Date
    February 7, 2008
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    D4; H4, 6: INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TILRESEKTION PROCEDURE, AFTER FIRING THE INSTRUMENT DID NOT OPEN ANYMORE, SURGEON USED SECOND INSTRUMENT TO CUT OUT FIRST ONE, NO FURTHER INFORMATION IS AVAILABLE. ANOTHER LIKE DEVICE WAS USED. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON 60 ENDOPATH STAPLER GDW ETHICON ENDO SURGERY, INC. (CINCINNATI) NA D4JW1J

    Patients

    Seq Age Sex Outcome Treatment
    1