BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA ROTICULATOR 60-3.5 SULU

    MDR report key: 3800282 · Received May 2, 2014

    Report

    Report Number
    1219930-2014-00345
    Event Type
    Injury
    Date Received
    May 2, 2014
    Date of Event
    March 22, 2014
    Report Date
    April 9, 2014
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K900129
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: BARIATRIC PROCEDURE. ACCORDING TO THE REPORTER: THE STAPLING WAS NOT COMPLETE. THE LOAD CUT BUT DID NOT STAPLE. THERE WAS BLEEDING IN EXCESS, BUT IT WAS NOT OVER 500CC. THE SURGICAL TIME WAS EXTENDED BY 1 HOUR TO PERFORM A MANUAL SUTURE. THE EVENT PROLONGED THE HOSPITAL STAY DURING 1 WEEK TO PREVENT A FISTULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263790 ENDO GIA ROTICULATOR 60-3.5 SULU DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY US SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention