BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60 ENDOPATH STAPLER

    MDR report key: 1831725 · Received January 8, 2008

    Report

    Report Number
    1527736-2008-00155
    Event Type
    Malfunction
    Date Received
    January 8, 2008
    Date of Event
    December 18, 2007
    Report Date
    December 21, 2007
    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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON THE SIXTH FIRING OF THE DEVICE THE STAPLE LINE HAD AN UNFORMED STAPLE ACROSS THE JEJUNUM. THE STAPLE LINE WAS OVERSEWN TO COMPLETE THE CASE. THERE WAS NO REPORTED 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 D4JE2E

    Patients

    Seq Age Sex Outcome Treatment
    1