Adverse Events in Robotic Surgery: A Retrospective Study of 14 Years of FDA Data
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. M...
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| Format: | Article |
| Language: | en_US |
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Public Library of Science
2017
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| Online Access: | http://hdl.handle.net/1721.1/109459 https://orcid.org/0000-0001-6294-8890 |
| _version_ | 1811084396104515584 |
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| author | Alemzadeh, Homa Raman, Jaishankar Kalbarczyk, Zbigniew Iyer, Ravishankar K. Leveson, Nancy G |
| author2 | Massachusetts Institute of Technology. Department of Aeronautics and Astronautics |
| author_facet | Massachusetts Institute of Technology. Department of Aeronautics and Astronautics Alemzadeh, Homa Raman, Jaishankar Kalbarczyk, Zbigniew Iyer, Ravishankar K. Leveson, Nancy G |
| author_sort | Alemzadeh, Homa |
| collection | MIT |
| description | 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. |
| first_indexed | 2024-09-23T12:50:03Z |
| format | Article |
| id | mit-1721.1/109459 |
| institution | Massachusetts Institute of Technology |
| language | en_US |
| last_indexed | 2024-09-23T12:50:03Z |
| publishDate | 2017 |
| publisher | Public Library of Science |
| record_format | dspace |
| spelling | mit-1721.1/1094592022-09-28T10:20:11Z Adverse Events in Robotic Surgery: A Retrospective Study of 14 Years of FDA Data Alemzadeh, Homa Raman, Jaishankar Kalbarczyk, Zbigniew Iyer, Ravishankar K. Leveson, Nancy G Massachusetts Institute of Technology. Department of Aeronautics and Astronautics Leveson, Nancy G 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. National Science Foundation (U.S.) (CNS 15-45069) National Science Foundation (U.S.) (CNS 13- 14891) 2017-05-31T15:04:50Z 2017-05-31T15:04:50Z 2016-04 2015-11 Article http://purl.org/eprint/type/JournalArticle 1932-6203 http://hdl.handle.net/1721.1/109459 Alemzadeh, Homa; Raman, Jaishankar; Leveson, Nancy; Kalbarczyk, Zbigniew and Iyer, Ravishankar K. "Adverse Events in Robotic Surgery: A Retrospective Study of 14 Years of FDA Data." PLOS ONE 11, no. 4 (April 2016): e0151470 © 2016 Alemzadeh et al https://orcid.org/0000-0001-6294-8890 en_US http://dx.doi.org/10.1371/journal.pone.0151470 PLOS ONE Creative Commons Attribution http://creativecommons.org/licenses/by/4.0/ application/pdf Public Library of Science Public Library of Science |
| spellingShingle | Alemzadeh, Homa Raman, Jaishankar Kalbarczyk, Zbigniew Iyer, Ravishankar K. Leveson, Nancy G Adverse Events in Robotic Surgery: A Retrospective Study of 14 Years of FDA Data |
| title | Adverse Events in Robotic Surgery: A Retrospective Study of 14 Years of FDA Data |
| title_full | Adverse Events in Robotic Surgery: A Retrospective Study of 14 Years of FDA Data |
| title_fullStr | Adverse Events in Robotic Surgery: A Retrospective Study of 14 Years of FDA Data |
| title_full_unstemmed | Adverse Events in Robotic Surgery: A Retrospective Study of 14 Years of FDA Data |
| title_short | Adverse Events in Robotic Surgery: A Retrospective Study of 14 Years of FDA Data |
| title_sort | adverse events in robotic surgery a retrospective study of 14 years of fda data |
| url | http://hdl.handle.net/1721.1/109459 https://orcid.org/0000-0001-6294-8890 |
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