BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIA UNIVERSAL W/ENDO GIA ROT. DLU 45-3.5

    MDR report key: 1030042 · Received April 15, 2008

    Report

    Report Number
    1219930-2008-00299
    Event Type
    Injury
    Date Received
    April 15, 2008
    Date of Event
    March 11, 2008
    Report Date
    March 12, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PROCEDURE: SIGMOIDECTOMY. ACCORDING TO THE RPTR: THE STAPLES DIDN'T CLOSE AND TISSUE WAS NOT TRANSECTED. THERE WAS NO BLEEDING OR TISSUE LOSS. TWENTY MINS WAS ADDED TO SURGERY TIME. TISSUE WAS RESECTED AND RESTAPLED TO CORRECT THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GIA UNIVERSAL W/ENDO GIA ROT. DLU 45-3.5 SURGICAL STAPLING DEVICE GDW NORTH HAVEN - USS N6K170M

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention