Safety Implications of Robotic Surgery: A Study of 13 Years of FDA Data on da Vinci Surgical Systems

摘要

Robotic surgical systems are intended to enable surgeons to perform minimally invasive operations with increased vision, precision, dexterity, and control, and to reduce the rate of injuries, blood loss, length of hospital stay, and post-operative complications. Recently, concerns regarding the safety and effectiveness of robot-assisted surgeries have heightened as an increased number of adverse events associated with the surgical robots have been reported to the U.S. Food and Drug Administration (FDA). Our study focuses on the analysis of the adverse events and recalls of da Vinci surgical systems, collected by the FDA over a period of 13 years from 2000 to 2012. We use the data on deaths, injuries, and robot malfunctions, combined with the technical problems and corresponding recovery actions taken by the company (provided by the recalls), together with systematic accident analysis using a tool called CAST. Using an automated natural language parsing tool trained with domain-specific dictionaries and part-of-speech and negation taggers, we extracted valuable information on the potential causes of robotic accidents in order to understand the effectiveness of using robotic devices for different minimally invasive procedures. We found that despite the increasing number of procedures being done with the da Vinci surgical system, a significant number of malfunctions and system downtimes with potentially adverse impacts on patients are being experienced. We provide insights on the use of existing state-of-the-art technologies for enhancing safety in future robotic surgical systems.