BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA ROTICULATOR 60-3.5 SULU

    MDR report key: 1844809 · Received September 22, 2010

    Report

    Report Number
    1219930-2010-00733
    Event Type
    Injury
    Date Received
    September 22, 2010
    Date of Event
    July 15, 2010
    Report Date
    September 9, 2010
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K06109
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    ACCORDING TO THE RPTR: THE ANASTOMOSIS WAS INCOMPLETE AND LEAKING. A NEW ANASTOMOSIS WAS DONE WITH RESECTION OF ADD'L TISSUE. SURGERY TIME EXTENSION WAS REPORTED AS MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA ROTICULATOR 60-3.5 SULU DISPOSABLE STAPLER GDW UNITED STATES SURGICAL N0D0624

    Patients

    Seq Age Sex Outcome Treatment
    1 ENDO GIA UNIVERSAL 12MM SINGLE USE INST, (B)(4)