BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA ROTICULATOR 60-4.8 SULU

    MDR report key: 2112323 · Received May 25, 2011

    Report

    Report Number
    1219930-2011-00441
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    April 15, 2011
    Report Date
    April 29, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: GASTRIC BAND. ACCORDING TO THE REPORTER: THE BACKSIDE OF THE STOMACH WAS BROKE, AND IT WAS SUTURED BY THE PHYSICIAN. THE PROBLEM WAS CAUSED BY THE RELOAD. AT THE DISTAL END OF THE UNIT A FORMED STAPLED STAYED ON THE UNIT AND PROVOKED A 1 CM HOLE IN THE FACE OF THE STOMACH WHEN THE INSTRUMENT WAS REMOVED. THE AFFECTED AREA WAS SUTURED. THERE WAS NO BLOOD LOSS OR UNANTICIPATED TISSUE LOSS NOR WAS THE SURGICAL TIME EXTENDED MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA ROTICULATOR 60-4.8 SULU DISPOSABLE SURGICAL STAPLING DEVICE GDW UNITED STATES SURGICAL N0K0219

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention