AUA 2018: Adverse Events Reported With Da Vinci Surgical Systems Over the Last Decade

San Francisco, CA USA (UroToday.com) Intuitive Surgical, the maker of the robotic platform commonly utilized in many North American and European systems, has had a major impact on the face of urologic surgery. Many urologic operations are now routinely being done robotically (with or without evidence to support it, unfortunately) – and the field is unlikely to ever go back. However, early reports of significant complications in inexperienced hands tempered the enthusiasm for robotic surgery, while more recent studies have demonstrated that there is a steep learning curve associated with success.

In this study, the authors assess the FDA Manufacturer and User Facility Device Experience (MAUDE) database, which documents all reported complications related to the device – they specifically assessed all entries in which the manufacturer was ″Intuitive Surgical″ between the years 2007 to 2017 (11 years). They then compared this to the rate of robotic procedures done per year (provided by the company itself).

From the database, 21,129 adverse events were reported - categorized as: 284 (1.34%) were ″Death″; 1,888 (8.94%) were ″Injury″; 17,830 (84.39%) ″Malfunction″; and 1,127 (5.33%) were ″Other.″

Accounting for case volume per year, the rate of reported ″Deaths″ peaked in 2012 (12.00 per 100,000 surgeries) and declined to 1.46 in 2016; the rate of ″Injuries″ peaked in 2012 (70.44 per 100,000 surgeries) and declined to 17.80 in 2016; and the rate of ″Malfunctions″ peaked in 2013 (1033.46 per 100,000 surgeries) and declined to 110.89 in 2016.

During this time, newer models (Si, Xi) have been introduced, training programs have increasingly emphasized robotic training, and the company has increased physician training and mentoring – all of which may explain the drop.

However, it should be noted that there was a very big jump from 2011 to 2012 and a steep drop from 2013 to 2014 – it is unclear why these two years were so prominent. Reporting the FDA may also account for the trends seen, and it is unclear what the requirement to report is or how these events are captured.

Limitations / Discussion Points:
1. The robotic procedures completed was provided by Intuitive Surgical and not by an independent source. Hence, this should be taken with a grain of salt.

2. Granularity regarding the complications is lacking due to the nature of the database. Further detail re: “injury” and “malfunction” would be helpful.

3. Reporting the FDA may also account for the trends seen, and it is unclear what the requirement to report is or how these events are captured.

Presenter: Hanson H Zhao MD

Co-Authors: Colby P. Souders, Farnoosh Nik-Ahd, Justin Houman, Bilal Chughtai, Jennifer T. Anger

Written by: Thenappan Chandrasekar, MD, Clinical Fellow, University of Toronto, Twitter: @tchandra_uromd at the 2018 AUA Annual Meeting - May 18 - 21, 2018 – San Francisco, CA USA