Adverse Events in Robotic Surgery: A Retrospective Study of 14 Years of FDA Data
By Homa Alemzadeh, R. Iyer, Zbigniew T. Kalbarczyk, Nancy G. Leveson, J. Raman. 2015
377 citations recorded by the source corpus.
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.
Subfields: Cardiology and Cardiovascular Medicine, Emergency Medical Services, Surgery
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Citations in the corpus
- On the Safety of Machine Learning: Cyber-Physical Systems, Decision Sciences, and Data Products (2016, methodology): “As one example in the medical devices domain, we have mined a large database of adverse events to obtain exactly uch characterizations [11].”
- Do Not Trust Additive Explanations (2019, background): “The list of such cases range from accidents while using surgical robots that cause minor injuries to patients (Alemzadeh et al., 2016) to problems with automated criminal justice technologies (Wexler, 2017) or incorrect predictions of air quality (McGough, 2018).”
- Micro/Nanorobots for Biomedicine: Delivery, Surgery, Sensing, and Detoxification (2017, background): “Despite widespread adoption of robotic systems for minimally invasive surgery, there are still major technical difficulties and challenges (4).”
- Systems-Theoretic Safety Assessment of Robotic Telesurgical Systems (2015, background): “015: Authors. or reschedule it to a later date (24.8%). (Note that these categories are not mutually exclusive. In some cases after several system resets, the procedure was converted or rescheduled.) [2]. This data shows the importance of designing robust safety features in robotic surgical systems ”
- Ethics and governance of trustworthy medical artificial intelligence (2023, background): “Between 2000 and 2013, surgical robots in the United States were responsible for at least 1,391 harm-causing incidents and 144 deaths [48].”