Abstract

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Author(s):: RAO Lan1; ZHANG Peiming2; CHAI Gang3; GAO Zhong4; 1. School of Medical Instrument and Food Engineering, University of Shanghai for Science and Technology, Shanghai 200093, China; 2. School of Medical Instrument, Shanghai University of Medicine & Health Sciences, Shanghai 201318, China; 3. Department of Plastic and Reconstruction Surgery, Shanghai Ninth People’s Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200011, China; 4. Shanghai Testing and Inspection Institute for Medical Devices, Shanghai 201318, China

Keywords:: Keywords: real-world data; Da Vinci surgical robot; adverse event; safety

Abstract:: Abstract: Objective To investigate the use of Da Vinci robotic surgery system in clinic for reducing safety accidents and enhancing the safety of the system. Methods The MAUDE database of FDA was used as the source of real-world data. According to the classification of adverse events in the FDA MAUDE database, the adverse event reports of Da Vinci robotic surgery system were classified into "Malfunction", "Injury", "Death", "Others" and "No Answers Provided" for statistical analysis, and the types of system malfunctions and the reasons causing injuries or deaths were analyzed. Results The number of total adverse events in the past decade changed from a rapid rise to a gradual decline. The number of adverse events in equipment malfunctions had gradually increased since 2014, and was declined in 2018. Due to the compound growth rate of Da Vinci robotic surgery system and the increased frequency of use, the number of adverse events in the Da Vinci robotic surgery system that caused deaths and injuries reached the peak in 2013. Conclusion With the increasing application of Da Vinci robotic surgery system, safety accidents frequently occur. By providing doctors with the enhanced training of system operations, reducing the rate of equipment malfunctions and being?staffed?with professional instrument maintenance personnel, the safety of the system can be effectively improved.