BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERED MULTIFIRE ENDO GIA 60-2.5 DLU

    MDR report key: 1030047 · Received April 15, 2008

    Report

    Report Number
    1219930-2008-00293
    Event Type
    Injury
    Date Received
    April 15, 2008
    Date of Event
    March 14, 2008
    Report Date
    March 21, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GCJ
    PMA / PMN Number
    K913802
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT SENT TO FDA ON 04/15/2008.

    Description of Event or Problem · 1

    PROCEDURE: GASTRECTOMY. ACCORDING TO THE REPORTER: THE JAWS WERE CLOSED ONCE AND OPENED TO CHECK IF ANY OBSTRUCTIONS WERE INCORPORATED. THEN, THE SURGEON NOTICED THE BOWEL HAD A HOLE ON IT. THE HOLE WAS SUTURED MANUALLY AND THE SITE WAS ANASTOMOSED BY FEE. NO BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED MULTIFIRE ENDO GIA 60-2.5 DLU UNK GCJ NORTH HAVEN - USS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention