BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60 ENDOPATH STAPLER

    MDR report key: 1810057 · Received November 12, 2007

    Report

    Report Number
    1527736-2007-07513
    Event Type
    Malfunction
    Date Received
    November 12, 2007
    Date of Event
    October 16, 2007
    Report Date
    October 22, 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
    CA, 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 DURING A ROUX-EN-Y PROCEDURE, THE STAPLE LINE WAS NOT FORMED AND THE STAPLES WERE OPEN DOWN ONE SIDE ON THE STAPLE LINE. A RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1