Abstract：Objective This paper aimed to explore the countermeasures to avoid adverse events by analyzing the adverse events of
electrosurgical, cutting & coagulation & accessories equipment in the MAUDE public database of FDA in recent five years and
describing the causes of adverse events. Methods The events marked as DEAD in the retrieval result were read and identified one by
one, and the events marked as Injury and product recall data were statistically classified. Results The use and management problems
accounted for 29.27% of the deaths, which could be reduced by strengthening management of medical institutions and training by
manufacturers. Equipment broke accounted for 9.76% in death events, which could be reduced by strengthening the maintenance and
testing of electrosurgical equipment. Conclusion Medical institutions should strengthen the maintenance and testing management of
electrosurgical equipment, and equipment manufacturers should strengthen the operation training of users.
陆晓华，宋海峰. 基于FDA数据库的电外科设备不良事件分析与对策[J]. 中国医疗设备, 2020, 35(5): 154-160.
LU Xiaohua, SONG Haifeng. Analysis and Prevention of Electrosurgical Adverse Events Based on FDA Database. China Medical Devices, 2020, 35(5): 154-160.
