BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE ILS CURVED CIR STAPL

    MDR report key: 1100903 · Received August 6, 2008

    Report

    Report Number
    3005075853-2008-00933
    Event Type
    Injury
    Date Received
    August 6, 2008
    Report Date
    July 14, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 08/06/2008. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SIGMA PROCEDURE, ONE DAY AFTER THE PROCEDURE, THE ANASTOMOSIS BECAME INCOMPLETE. A REOPERATION WAS REQUIRED. BLUE TEST DURING SURGERY WAS O.K. THERE IS NO FURTHER INFO AVAILABLE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention