探索吻合器行业标准中可能存在的问题  

Explore Possible Problems of Stapler Industry Standards

作　　者：张道君 唐雯 于琦 ZHANG Dao-jun;TANG Wen;YU Qi(Center for Certification&Evaluation,JSFDA,Jiangsu Nanjing 210002)

机构地区：[1]江苏省食品药品监督管理局认证审评中心

出　　处：《中国医疗器械信息》2020年第3期10-11,共2页China Medical Device Information

摘　　要：文章通过对吻合器(管型吻合器、肛肠吻合器、直线型吻合器、直线切割吻合器、腔镜下直线切割吻合器)不良事件的调研,发现绝大多数的不良事件和产品的设计有一定的关联,进而主要探索吻合器行业标准中是否可能存在一定的问题有待完善,从根本上减少不良事件的发生。Through investigating the adverse events of stapler(Circular stapler,Anorectal Stapler,Linear stapler,Linear cutter stapler,laparoscopic Linear cutter stapler),we found that most of the adverse events are related to product design to some extent,and further explore whether there may be some problems in the stapler industry standards to be improved so as to fundamentally reduce the occurrence of adverse events.

关 键 词：吻合器 管型吻合器 标准 不良事件 

分 类 号：TH789[机械工程—仪器科学与技术]