BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH SURGIDAC 2/0 48 GRN DLU SU

    MDR report key: 2133269 · Received May 11, 2011

    Report

    Report Number
    1219930-2011-00364
    Event Type
    Malfunction
    Date Received
    May 11, 2011
    Date of Event
    March 28, 2011
    Report Date
    April 2, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP GASTRIC BYPASS. ACCORDING TO THE REPORTER: AFTER THE SUTURE WAS LOADED AND INTRODUCED INTO THE ABDOMINAL CAVITY, THE SURGEON COMPLETED 1ST THROW AND SUTURE BROKE IN THE MIDDLE OF THE STRAND. BOX OF EACH WAS SET ASIDE AND A NEW BOX OPENED. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 250CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. THERE WAS NO TISSUE DAMAGE OR UNANTICIPATED TISSUE LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO STITCH SURGIDAC 2/0 48 GRN DLU SU DISPOSABLE SUTURING DEVICE SULU KOG UNITED STATES SURGICAL N0H0007

    Patients

    Seq Age Sex Outcome Treatment
    1