Mini-Sentinel: Utilization of the DaVinci Device and Other Robotic-Assisted Devices

    Basic Details
    Date Posted
    Wednesday, January 22, 2020
    Status
    Complete
    Medical Product
    robotic-assisted procedure
    Description

    This request investigated prevalent use of robotic-assisted procedures in the Mini-Sentinel Distributed Database (MSDD). In addition, this request analyzed use of laparoscopic robotic assistance for several specified primary procedures. This request contains 3 reports:

    • Report 1 presents results for the robotic-assisted procedures codes only.
    • Report 2 also presents results for use of robotic-assisted codes with specified primary procedures.
    • Report 3 presents results for use of robotic-assisted codes with specified primary procedures.

    Data from October 1, 2008 to December 31, 2012 from 18 Data Partners contributing to the MSDD were included in this report. This request was distributed to Data Partners on July 29, 2013.

    Additional Details
    FDA Center
    CDRH
    Time Period
    October 1, 2008 - December 31, 2012
    Study Type
    Modular Program
    Assessment Type
    Exploratory Analyses
    Population / Cohort
    All individuals
    Data Sources
    Mini-Sentinel Distributed Database (MSDD)