BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVIDIEN

    MDR report key: 6030244 · Received October 12, 2016

    Report

    Report Number
    MW5065385
    Event Type
    Malfunction
    Date Received
    October 12, 2016
    Date of Event
    August 30, 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 SLEEVE GASTRECTOMY, HIATAL HERNIA REPAIR. DURING THE ROBOTIC GASTRIC SLEEVE THE IDRIVE STAPLER WOULD NOT ACTIVATE. A SECOND UNIT WAS OBTAINED, INSERTED AND IT ALSO FAILED. MANUAL STAPLER WAS UTILIZED. CASE WAS COMPLETED WITH NO HARM TO THE PATIENT. THE COVIDIEN REPRESENTATIVE WAS AVAILABLE DURING THE CASE, AND HAS INSPECTED THE ITEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675649 COVIDIEN IDRIVE LAPAROSCOPIC STAPLER GDW COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR