BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA UNIVERSAL XL

    MDR report key: 1781762 · Received July 26, 2010

    Report

    Report Number
    MW5016883
    Event Type
    Malfunction
    Date Received
    July 26, 2010
    Date of Event
    July 12, 2010
    Report Date
    July 26, 2010
    Manufacturer
    AUTOSUTURE US HEADQUARTERS COVIDIEN
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    INSTRUMENT STOPPED WORKING DURING CASE MALFUNCTIONED WHEN LOAD WAS PUT IN AND WOULD NOT TURN, TRIED NEW LOAD AND STILL WOULD NOT WORK. MORBID OBESITY. ENDO GIA UNIVERSAL XL AUTO SUTURE. SURGEON: CLINICAL: (B)(6), RN SPECIALTY COORDINATOR: GENERAL AND NEURO SURGERY TISSUE COORDINATOR (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA UNIVERSAL XL ENDO GIA GDW AUTOSUTURE US HEADQUARTERS COVIDIEN N9L0465

    Patients

    Seq Age Sex Outcome Treatment
    1 Other