BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA II 60-3.5 SULU

    MDR report key: 2190454 · Received July 29, 2011

    Report

    Report Number
    2647580-2011-00511
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 14, 2011
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAPAROSCOPIC COLECTOMY. ACCORDING TO THE REPORTER: THE HANDLE COULD BE FULLY SQUEEZED, BUT THE STAPLES GOT INTO THE SLIT OF THE CARTRIDGE, SO THE DEVICE WAS STUCK ON THE TISSUE. OOZING OCCURRED. EVENTUALLY, IT COULD BE REMOVED. IT TOOK MORE THAN 30 MINUTES TO REMOVE THE DEVICE. THE PATIENT WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA II 60-3.5 SULU DISPOSABLE SURGICAL STAPLING DEVICE GDW USSC PUERTO RICO P1B0838

    Patients

    Seq Age Sex Outcome Treatment
    1 Other