BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA UNIVERSAL ROTICULATOR

    MDR report key: 1426366 · Received July 13, 2009

    Report

    Report Number
    1426366
    Event Type
    Malfunction
    Date Received
    July 13, 2009
    Date of Event
    June 23, 2009
    Report Date
    July 12, 2009
    Manufacturer
    COVIDIEN UNITED STATES SURGICAL CORPORATION
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING SURGERY: RIGHT VIDEO ASSISTED THORACOSCOPIC LOBECTOMY A 12MM ENDO GIA STAPLER WAS USED. TWO RELOADS DID NOT OPEN AFTER SURGEON INSERTED STAPLER WITH RELOAD INTO PATIENT. THE FIRST RELOAD WAS A 30-2.5 ENDO GIA UNIVERSAL ROTICULATOR # 030451. THE SECOND RELOAD WAS A 45-4.8 ENDO GIA UNIVERSAL ROTICULATOR # 030456. BOTH RELOADS WERE CLEANED AND SAVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA UNIVERSAL ROTICULATOR STAPLER, RELOAD, SURGICAL GDW COVIDIEN UNITED STATES SURGICAL CORPORATION * N9E0099

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR