BEUDAMED
    FDA Adverse Event Summary report: N

    INTUITIVE SURGICAL INC

    MDR report key: 7685115 · Received July 12, 2018

    Report

    Report Number
    MW5078357
    Date Received
    July 12, 2018
    Date of Event
    June 29, 2018
    Report Date
    July 2, 2018
    Manufacturer
    INTUITIVE SURGICAL INC.
    Product Code
    GDW
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    STAPLER FAILED TO CALIBRATE AND FIRE. SPOKE WITH INTUITIVE TECH SUPPORT. INTUITIVE SAID MOST LIKELY THE MAIN SCREW DRIVE WAS CAUSING THE ISSUE. REMOVED FROM THE FIELD. NO PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525942 INTUITIVE SURGICAL INC DA VINCI SI ENDOWRIST STAPLER 45 GDW INTUITIVE SURGICAL INC. DA VINCI SI S10170426

    Patients

    Seq Age Sex Outcome Treatment
    1