Adverse Events in Robotic Surgery: A Retrospective Study of 14 Years of FDA Data

PLoS One. 2016 Apr 20;11(4):e0151470. doi: 10.1371/journal.pone.0151470. eCollection 2016.

Abstract

Background: Use of robotic systems for minimally invasive surgery has rapidly increased during the last decade. Understanding the causes of adverse events and their impact on patients in robot-assisted surgery will help improve systems and operational practices to avoid incidents in the future.

Methods: By developing an automated natural language processing tool, we performed a comprehensive analysis of the adverse events reported to the publicly available MAUDE database (maintained by the U.S. Food and Drug Administration) from 2000 to 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 potential causes for catastrophic events such as 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 (mean = 83.4, 95% confidence interval (CI), 74.2-92.7 per 100,000 procedures) over the years. Surgical specialties for which robots are extensively used, such as gynecology and urology, had lower numbers of injuries, deaths, and conversions per procedure than more complex surgeries, such as cardiothoracic and head and neck (106.3 vs. 232.9 per 100,000 procedures, 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 all 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 (2.5%).

Conclusions: Despite widespread adoption of robotic systems for minimally invasive surgery in the U.S., a non-negligible number of technical difficulties and complications are still being experienced during procedures. Adoption of advanced techniques in design and operation of robotic surgical systems and enhanced mechanisms for adverse event reporting may reduce these preventable incidents in the future.

Publication types

  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Databases, Factual*
  • Equipment Failure / statistics & numerical data*
  • Humans
  • Laparoscopy / adverse effects*
  • Retrospective Studies
  • Robotics / instrumentation*
  • United States
  • United States Food and Drug Administration

Grant support

This research was supported, in part, by grants no. NSF CNS 15-45069 and NSF CNS 13-14891 from the National Science Foundation, Jump ARCHES Endowment for Engineering and Health Care Innovation from the OSF Foundation (Peoria, IL), an unrestricted grant from Infosys, and a faculty award from IBM (HA, ZK, and RKI received the funding). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.