BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EGIA 60 ARTICULATING MED/THICK SULU

    MDR report key: 2243856 · Received September 7, 2011

    Report

    Report Number
    1219930-2011-00770
    Event Type
    Injury
    Date Received
    September 7, 2011
    Report Date
    August 25, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K083519
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: UNKNOWN. ACCORDING TO THE REPORTER: THE SURGEON FIRED ON TISSUE BUT IT RESULTED IN POOR STAPLE FORMATION. HE STAPLED ANOTHER DEVICE OVER THE PREVIOUS ONE RESULTING IN UNANTICIPATED TISSUE LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EGIA 60 ARTICULATING MED/THICK SULU DISPOSABLE SURGICAL STAPLING DEVICE GDW UNITED STATES SURGICAL N0L0430UL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other