BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVIDIEN

    MDR report key: 6030246 · Received October 12, 2016

    Report

    Report Number
    MW5065387
    Event Type
    Malfunction
    Date Received
    October 12, 2016
    Date of Event
    September 15, 2016
    Report Date
    October 12, 2016
    Manufacturer
    COVIDIEN
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: ROBOT ASSISTED LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS, HIATAL HERNIA REPAIR. WHILE USING THE ENDO STAPLER DURING THE PROCEDURE, IT WOULD NOT FIRE. A NEW STAPLER WAS BROUGHT IN AND THE CASE WAS FINISHED WITHOUT INCIDENT. THE COVIDIEN REPRESENTATIVE WAS PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675508 COVIDIEN ENDO GIA ULTRA UNIVERSAL STAPLER GDW COVIDIEN EGIAUXL P6F0526X

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR