BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA ROTICULATOR 45-3.5 SULU

    MDR report key: 1900110 · Received November 9, 2010

    Report

    Report Number
    1219930-2010-00832
    Event Type
    Injury
    Date Received
    November 9, 2010
    Date of Event
    October 7, 2010
    Report Date
    October 13, 2010
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K0
    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: WEDGE RESECTION. ACCORDING TO THE REPORTER: AFTER FIRING, IT WAS NOTICED THAT TISSUE WAS TRANSECTED, BUT STAPLES DID NOT FORM PROPERLY. ADDITIONAL MANUAL SUTURING WAS DONE FOR RECOVERY. BLEEDING WAS REPORTED AS UNDER 200CC. SURGERY TIME WAS EXTENDED BY MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA ROTICULATOR 45-3.5 SULU DISPOSABLE STAPLER GDW UNITED STATES SURGICAL N0G0404

    Patients

    Seq Age Sex Outcome Treatment
    1 Other