BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA ROTICULATOR 45-3.5 SULU

    MDR report key: 2140459 · Received June 15, 2011

    Report

    Report Number
    1219930-2011-00500
    Event Type
    Injury
    Date Received
    June 15, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 7, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAPAROSCOPIC COLON PROCEDURE. ACCORDING TO THE RPTR: MALFORMED STAPLING OCCURRED. CONVERTED TO OPEN SURGERY. NO UNANTICIPATED BLEEDING OCCURRED. NOTHING FELL INTO THE PT CAVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA ROTICULATOR 45-3.5 SULU DISPOSABLE SURGICAL STAPLING DEVICE GDW UNITED STATES SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other CATALOG # 030449, LOT: N0M0357,| EXPIRATION: 12/31/2015, MANUFACTURED: 12/2010,| 510K: K061095| ENDO GIA UNIVERSAL 12MM SINGLE USE INSERT: