BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE ILS CURVED CIR STAPL

    MDR report key: 1003640 · Received February 14, 2008

    Report

    Report Number
    1527736-2008-00888
    Event Type
    Malfunction
    Date Received
    February 14, 2008
    Date of Event
    December 11, 2007
    Report Date
    January 31, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DEVICES WERE USED DURING AN OPEN SIGMOID COLECTOMY, THE FIRST DEVICE PRODUCED A LEAK IN THE ANASTOMOSIS. THE SECOND DEVICE FIRED AND THE ANVIL FELL INTO THE PT, IT IS UNK IF THERE WAS A CUT OR STAPLE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE ILS CURVED CIR STAPL GDW ETHICON ENDO-SURGERY, INC. (CINCINNATI) NI UNK

    Patients

    Seq Age Sex Outcome Treatment
    1