基于FDA MAUDE数据库的手术机器人不良事件数据的智能化分析  

Intelligent analysis of adverse event data of surgical robot based on FDA MAUDE database

作　　者：夏兵 王新茹 马雪皎 王丽 饶兰 张培茗[3] XIA Bing;WANG Xin-ru;MA Xue-jiao;WANG Li;RAO Lan;ZHANG Pei-ming(Center for Drug Reevaluation of Henan,Zhengzhou 450008,China;Shanghai United Imaging Healthcare Co.,Ltd.,Shanghai 201807,China;School of Health Sciences and Engineering,University of Shanghai for Science and Technology,Shanghai 200093,China)

机构地区：[1]河南省药品评价中心,郑州450008 [2]上海联影医疗科技有限公司,上海201807 [3]上海理工大学健康科学与工程学院,上海200093

出　　处：《医疗卫生装备》2023年第2期76-84,共9页Chinese Medical Equipment Journal

基　　金：国家重点研发计划资助项目(2018YFB1307700);上海市科委技术标准专项(18DZ2201900)。

摘　　要：检索了美国食品药品监督管理局(Food and Drug Administration,FDA)制造商和用户设施设备体验(Manufa-cturer and User Facility Device Experience,MAUDE)数据库中2000—2021年的达芬奇机器人手术系统不良事件数据,利用Python对所有不良事件进行了智能化处理与分析,重点阐述了达芬奇机器人手术系统的不良事件变化趋势、应用科室分布和各类不良事件占比、主要设备故障类型、2013—2019年的手术量及分布科室,为达芬奇机器人手术系统安全性评价提供了临床证据。The data retrieval was carried out on the adverse events of Da Vinci robotic surgery system in the database of Manufacturer and User Facility Device Experience(MAUDE)of Food and Drug Administration(FDA)from 2000 to 2021.All the adverse events were intelligently processed and analyzed using Python,focusing on the trends of adverse events,the distribution of departments and the proportion of various types of adverse events,the main equipment failure types,the volume of surgery and the involved departments from 2013 to 2019.Clinical evidences were provided for evaluating the safety of Da Vinci robotic surgery system.

关 键 词：达芬奇机器人手术系统 MAUDE数据库 不良事件 Python 手术机器人 

分 类 号：R612[医药卫生—外科学] TP242[医药卫生—临床医学] TP311.13[自动化与计算机技术—检测技术与自动化装置]