Adverse Events in Robotic Surgery: A Retrospective Study of 14 Years of FDA Data (1507.03518v2)

Abstract: Understanding the causes and patient impacts of surgical adverse events will help improve systems and operational practices to avoid incidents in the future. We analyzed the adverse events data related to robotic systems and instruments used in minimally invasive surgery, reported to the U.S. 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. 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%). Adoption of advanced techniques in design and operation of robotic surgical systems may reduce these preventable incidents in the future.

• The paper presents a comprehensive analysis of 10,624 adverse event reports from robotic surgeries using FDA MAUDE data.
• The study employs structured data extraction and natural language processing to classify incidents across six surgical specialties.
• The findings highlight major device malfunctions, with 75.9% of events including issues like electrical arcing and unintended instrument movements.

Analysis of Adverse Events in Robotic Surgery: Insights from a 14-Year Study of FDA Data

The paper "Adverse Events in Robotic Surgery: A Retrospective Study of 14 Years of FDA Data" presents an in-depth analysis of adverse events associated with robotic surgical systems reported from 2000 to 2013. Employing data from the FDA MAUDE database, this paper encompasses six major surgical specialties, detailing the frequency, causes, and impacts of deaths, injuries, and device malfunctions during robotic surgeries.

Methodology

The authors utilized the MAUDE database to extract reports pertinent to robotic systems employed in minimally invasive surgeries. Through a combination of structured data extraction and natural language processing of unstructured text, they identified adverse events, classified their types, and examined their implications. The paper adopted statistical methods to estimate event rates per procedure, leveraging annual procedural data from manufacturers to provide context to the reported incidents.

Key Findings

1. Adverse Event Statistics: The paper identified 10,624 adverse event reports, comprising 144 deaths (1.4%), 1,391 injuries (13.1%), and 8,061 device malfunctions (75.9%). It indicated a relative consistency in the rate of injury and death events per procedure since 2007.
2. Surgical Specialty Disparities: High complexity surgeries, such as cardiothoracic and head and neck surgeries, exhibited elevated rates of adverse events compared to more prevalent specialties like gynecology and urology. This difference may be attributed to the complexity and lower frequency of robotic interventions in these areas, leading to less established procedural expertise.
3. Device Malfunctions: A significant portion of adverse events stemmed from device malfunctions, including electrical arcing (10.5%), unintended instrument movements (8.6%), and video/imaging issues (2.6%). These malfunctions impacted procedure flow and patient outcomes, with 10.4% of events leading to procedure interruptions, including conversions to non-robotic methods or rescheduling.

Implications and Future Directions

The findings highlight the criticality of robust safety mechanisms and effective human-machine interfaces in robotic surgical systems. As robotic surgery becomes more integrated into complex surgical areas, enhanced safety protocols and team training are essential to mitigate risks. Future developments in surgical robotics should incorporate advanced monitoring systems, real-time error detection, and comprehensive training simulators to diminish the adverse event rate.

The paper also underlines the importance of consistent, transparent reporting in the MAUDE database to provide reliable data for ongoing safety evaluations. Recognizing underreporting issues remains crucial, as these may obscure the true prevalence of adverse events.

Conclusion

This comprehensive paper offers vital insights into the challenges and risks associated with robotic surgeries, emphasizing the need for continuous improvements in technology and practice. As robotic surgeries advance, integrating cutting-edge safety features and refining operator training will be imperative to enhance patient outcomes and optimize the surgical benefits of robotic systems. The work represents a substantial contribution to understanding and improving the safety and efficacy of robotic surgical interventions in the healthcare sector.