BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS*45 ENDO LIN CUT RELOAD WH

    MDR report key: 1823755 · Received July 27, 2007

    Report

    Report Number
    1527736-2007-04942
    Event Type
    Malfunction
    Date Received
    July 27, 2007
    Date of Event
    July 7, 2007
    Report Date
    July 19, 2007
    Manufacturer
    ETHICON ENDO-SURGERY, INC.(CINCINNATI)
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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 GASTRIC BYPASS PROCEDURE THE STAPLES WERE NOT FORMED COMPLETELY. A NEW RELOAD WAS USED. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS*45 ENDO LIN CUT RELOAD WH GDW ETHICON ENDO-SURGERY, INC.(CINCINNATI) NA D4GY2P

    Patients

    Seq Age Sex Outcome Treatment
    1