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

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.