BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    MDR report key: 731025 · Received June 29, 2006

    Report

    Report Number
    1219930-2006-00280
    Event Type
    Injury
    Date Received
    June 29, 2006
    Date of Event
    June 8, 2006
    Report Date
    June 12, 2006
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    USS REFERENCE #: 200606-0788..

    Description of Event or Problem · 1

    PROCEDURE: RECTOPEXI. REPORTEDLY, THE INSTRUMENT WAS FIRED OVER HEAVY TISSUE. THE INSTRUMENT FIRED AND CUT, BUT THE DEVICE STUCK ON THE TISSUE WITHOUT PROPERLY FORMING THE STAPLES. THE PATIENT HAS TO STAY IN THE INTENSIVE CARE UNIT, HOWEVER NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA UNIVERSAL 12MM SINGLE USE INST DISPOSABLE SURGICAL STAPLER GDW NORTH HAVEN - USS * N6B235

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN