BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE ILS CURVED CIR STAPL

    MDR report key: 1022798 · Received March 19, 2008

    Report

    Report Number
    1527736-2008-01687
    Event Type
    Injury
    Date Received
    March 19, 2008
    Report Date
    February 25, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 3/19/2008.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE INSTRUMENT WORKED WELL DURING SURGERY. A LEAK TEST WAS PERFORMED AND WAS FINE. TWO DAYS POSTOPERATIVELY, THE PATIENT SHOWED POSTOPERATIVE INSUFFICIENCY. THE PATIENT WAS TAKEN BACK TO SURGERY FOR A CONVERT TO OPEN PROCEDURE. THERE WAS NO OTHER PATIENT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE ILS CURVED CIR STAPL GDW ETHICON ENDO-SURGERY, LLC NA D4J132

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention