BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA II 60-3.5 SULU

    MDR report key: 597583 · Received April 28, 2005

    Report

    Report Number
    1219930-2005-00131
    Event Type
    Injury
    Date Received
    April 28, 2005
    Report Date
    April 5, 2005
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GCJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE INSTRUMENT DID NOT PLACE PROPERLY FORMED STAPLES ON THE TISSUE AND THE STAPLE CARTRIDGE WAS BENT AT THE DISTAL END. THEREFORE, ANOTHER SULU WAS APPLIED, RESULTING IN MINIMAL TISSUE LOSS. PROCEDURE: LGB PT STATUS: NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA II 60-3.5 SULU DISPOSABLE SURGICAL STAPLER GCJ NORTH HAVEN - USS NA N4K405

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention