BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO ROTICULATOR 60-4.8 SULU

    MDR report key: 3964850 · Received July 16, 2014

    Report

    Report Number
    1219930-2014-00542
    Event Type
    Injury
    Date Received
    July 16, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 25, 2014
    Manufacturer
    COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES
    Product Code
    GDW
    PMA / PMN Number
    K900129
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: LEFT UPPER LUNG MAST REMOVAL. ACCORDING TO THE REPORTER: THE JAW ON BOTH RELOADS WOULD NOT CLOSE ON THE STAPLE LINE. THERE WERE UNFORMED STAPLES IN THE MIDDLE OF THE STAPLE LINE. THE PATIENT WAS OPENED. THE DEFECT WAS CLOSED WITH SUTURE. PHYSICIAN SWITCHED TO A DIFFERENT RELOAD USING THE SAME HANDLE AND COMPLETED THE PROCEDURE. THERE WAS NO UNANTICIPATED TISSUE LOSS OR DAMAGE. PATIENT LOST TWO LITERS OF BLOOD. A TRANSFUSION WAS REQUIRED. OPERATING TIME WAS EXTENDED BY MORE THAN 30 MINUTES. NO REINFORCEMENT MATERIAL USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415924 ENDO ROTICULATOR 60-4.8 SULU DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES N3D0634LX

    Patients

    Seq Age Sex Outcome Treatment
    1