BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60 ENDOPATH STAPLER

    MDR report key: 1820765 · Received September 20, 2007

    Report

    Report Number
    1527736-2007-06213
    Event Type
    Malfunction
    Date Received
    September 20, 2007
    Date of Event
    August 29, 2007
    Report Date
    September 6, 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
    PA, 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 LAPAROSCOPIC GASTRIC BYPASS WITH ROUX EN Y THERE WERE MALFORMED STAPLES. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON 60 ENDOPATH STAPLER GDW ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA D4H522

    Patients

    Seq Age Sex Outcome Treatment
    1