Associated Incidents
Importance: Understanding the causes and patient impacts of surgical adverse events will help improve systems and operational practices to avoid incidents in the future.
Objective: To determine the frequency, causes, and patient impact of adverse events in robotic procedures across different surgical specialties.
Methods: We analyzed the adverse events data related to robotic systems and instruments used in minimally invasive surgery, reported to the U.S. Food and Drug Administration (FDA) MAUDE database from January 2000 to December 2013. We determined the number of events reported per procedure and per surgical specialty, the most common types of device malfunctions and their impact on patients, and the causes for catastrophic events such as major complications, patient injuries, and deaths.
Results: During the study period, 144 deaths (1.4% of the 10,624 reports), 1,391 patient injuries (13.1%), and 8,061 device malfunctions (75.9%) were reported. The numbers of injury and death events per procedure have stayed relatively constant since 2007 (mean=83.4, 95% CI, 74.2–92.7). Surgical specialties, for which robots are extensively used, such as gynecology and urology, had lower number of injuries, deaths, and conversions per procedure than more complex surgeries, such as cardiothoracic and head and neck (106.3 vs. 232.9, Risk Ratio = 2.2, 95% CI, 1.9-2.6). Device and instrument malfunctions, such as falling of burnt/broken pieces of instruments into the patient (14.7%), electrical arcing of instruments (10.5%), unintended operation of instruments (8.6%), system errors (5%), and video/imaging problems (2.6%), constituted a major part of the reports. Device malfunctions impacted patients in terms of injuries or procedure interruptions. In 1,104 (10.4%) of the events, the procedure was interrupted to restart the system (3.1%), to convert the procedure to non-robotic techniques (7.3%), or to reschedule it to a later time (2.5%).
Introduction
The use of robotic systems for minimally invasive surgery has exponentially increased during the last
decade. Between 2007 and 2013, over 1.74 million robotic procedures were performed in the U.S., of
which over 1.5 million (86%) were performed in gynecology and urology, while the number of
procedures in other surgical specialties altogether was less than 250,000 (14%)1
. Several previous studies
on the outcomes and rates of complications during robotic procedures in the areas of gynecology, urology,
and general surgery have been done. Yet no comprehensive study of the safety and reliability of surgical
robots has been performed.
Our study focuses on analysis of all the adverse events related to robotic surgical systems, collected by
the FDA MAUDE database2 during the 14-year period of 2000–2013. It covers the events experienced
during the robotic procedures in six major surgical specialties: gynecology, urology, general, colorectal,
cardiothoracic, and head and neck surgery. We analyzed the safety-related incidents, including deaths,
injuries, and device malfunctions, to understand their causes and measure their impact on patients and on
the progress of the surgery.
There have been several reports by different surgical institutions on occasional software-related,
mechanical, and electrical failures of system components and instruments during robotic procedures3-16. A
few studies analyzed the FDA MAUDE reports related to robotic surgical systems17-23 (see Tables 1 and 2
in Appendix). However, most of the previous work targeted only two common robotic surgical specialties
of gynecology and urology, or only analyzed small subsets or specific types of device failure modes (e.g.,
electro-cautery failures, electrosurgical injuries, instrument failures).
An important question is whether the evolution of the robotic systems with new technologies and features
over the years has improved the safety of robotic systems and their effectiveness across different surgical
specialties. Our goal is to use the knowledge gained from this analysis to provide insights on design of
future surgical systems that by taking advantage of advanced safety mechanisms, improved human...