摘要
目的:探究双极电凝设备在妇科手术中遇到的常见问题并探讨应对的措施。方法:收集2022年9月~2023年6月本院收治的行妇科腹腔镜下手术的患者共125例,记录术中遇到的设备故障及出现的患者伤害情况。结果:双极电凝装置在妇科手术中最常见的不良事件包括:钳头粘连组织,导致撕开组织时出血;电凝烟雾过大,影响手术视野;电凝后钳头焦痂多,止血效果变差;电凝效果不佳;钳头变形等。故障产生的主要原因包括:手术中未及时清理焦痂;电凝击发时间过长;电凝操作时夹持过紧;夹取组织过多、过厚;以及一些产品质量问题,如产品阻值过大,钳头的涂层处理不到位等。此外,对患者的伤害主要包括:增加手术时长;电凝点出血;止血效果差等。结论:双极电凝装置是重要的止血器械,目前在临床使用中仍然存在一些问题,究其原因主要是器械使用者的操作不当和器械本身设计以及材质的缺陷,因此进一步规范医疗器械的使用,加大医疗器械的研发力度至关重要。
Objective:To explore the bipolar electric coagulation equipment in common problems encountered in gynecological surgery and to explore measures to cope.Methods:A total of 125 cases of gynecological laparoscopic surgery were collected and recorded,including equipment failures and patient injuries during the operation.Results:Bipolar electric coagulation device in gynecologic surgery is the most common adverse events include:tong head adhesion,lead to tear apart when hemorrhage,electric coagulation smoke is too large,affect the surgical field,electric coagulation forceps after head eschar,hemostatic effect variation,poor electric coagulation effect,tong head deformation,etc.;The main causes of the failure include:not cleaning the eschar in time during the operation,too long time of electric coagulation,too tight clamping during electric coagulation operation,too much and too thick clamping tissue,and some product quality problems such as,too large resistance of the product,the coating treatment of the clamp head is not in place,etc.In addition,the harm to patients mainly included:increased operation time,electrocoagulation point bleeding,poor hemostasis,and so on.Conclusion:Bipolar coagulation device is an important hemostatic device,but there are still some problems in clinical use,mainly due to the improper operation of the device users and the defects in the design and material of the device itself.Therefore,it is very important to further standardize the use of medical devices and strengthen the research and development of medical devices.
作者
杨波
冯夫禹
张琦
毕景涛
巴磊
YANG Bo;FENG Fu-yu;ZHANG Qi;BI Jing-tao;BA Lei(Xuzhou Inspection and Testing Center,Jiangsu Xuzhou 221000;Xuzhou Maternal and Child Health Hospital,Jiangsu Xuzhou 221000;National Health Commission Family Planning Drug Adverse Reaction Monitoring Center,Jiangsu Nanjing 210003)
出处
《中国医疗器械信息》
2024年第11期174-176,共3页
China Medical Device Information
基金
江苏省卫生健康发展研究中心项目(项目名称:基于真实世界数据开展妇科手术结扎相关器械临床使用风险研究,项目编号:JSHD2022013)。
关键词
双极电凝设备
妇科手术
不良事件
bipolar coagulation equipment
gynecological surgery
adverse events
