达芬奇手术机器人设备故障模式分析及预防性维护策略研究OA
Analysis of equipment failure modes and preventive maintenance strategies for Da Vinci surgical robots
目的:分析达芬奇机器人手术系统的故障模式、规律及故障发生的根本原因,探讨并建立一套科学、高效的预防性维护策略,以提升设备可靠性、保障手术安全、控制运维成本.方法:回顾性分析 2022 年 1 月—2024 年 12 月于中国人民解放军东部战区总医院产生的 62 次达芬奇Si手术系统故障报修记录,采用故障模式、影响及危害性分析(FMECA)方法,对故障设备的型号、故障模块、现象、发生时机、维修时间、成本等数据进行归类统计和根因分析.结果:在 62 次手术机器人故障报修记录的 107 个独立故障事件中,机械臂系统(故障率38.32%)、成像系统(故障率 28.04%)和主控台系统(故障率18.69%)为故障高发模块;故障发生时机主要集中于手术中(45.79%)和开机自检阶段(32.71%).当责任方为原厂时,故障响应时间、诊断时间、维修时间、总停机时间均显著长于责任方为院内时,差异有统计学意义(P<0.05).机械臂(整套)的单次更换费用(18万元)与总成本(54万元)均为最高,EndoWrist手术器械的更换频次(29次)最高.FMECA分析显示,机械臂关节过载、立体物镜镜面污染、CCD相机老化等问题的风险优先数(RPN)最高.结论:达芬奇手术机器人的故障发生具有显著的规律性和模块集中性,针对性制定以周期性深度保养、关键部件寿命预测性更换,以及强化术中操作规范为核心的预防性维护策略,有利于降低高RPN故障的发生频率,从而保障患者手术安全.
Objective:To analyze the failure modes,patterns and underlying causes of the Da Vinci surgical robot,and to establish a scientific and efficient preventive maintenance strategy to improve equipment reliability,ensure surgical safety,and control operation and maintenance costs.Methods:A retrospective analysis was conducted on 62 repair records of the Da Vinci Si surgical system in the General Hospital of Eastern Theater Command from January 2022 to December 2024.Failure mode,effects,and criticality analysis(FMECA)was used to classify data including equipment model,failure modules,phenomena,occurrence timing,repair time,and maintenance costs for root cause analyzing.Results:Among the 107 individual failure events in the 62 fault repair records,the failure rates of the robotic arm(38.32%),imaging system(28.04%),and main console(18.69%)were the highest.Failures mostly occurred during surgery(45.79%)and during power-on self-check(32.71%).When responsibility lay with the original equipment manufacturer(OEM),mean response time,diagnostic time,repair time,and total downtime were significantly longer than those when responsibility lay with the hospital(P<0.05).The robotic arm(complete set)had the highest single replacement cost(180,000 CNY)and total cost(540,000 CNY),while EndoWrist surgical instruments showed the highest replacement frequency(29 times).FMECA showed that the highest risk priority numbers(RPN)were manipulator joint overload,stereoscopic lens surface contamination,CCD camera aging.Conclusion:Failures of Da Vinci surgical robot has significant regularity and module concentration.Developing targeted preventive maintenance strategies centered on periodic deep maintenance,predictive replacement of key components based on lifespan prediction,and strengthening intraoperative operational standards can reduce the frequency of high-RPN failures and ensure patient safety.
金鑫;袁翰超;叶源
中国人民解放军东部战区总医院秦淮医疗区医技保障科 江苏 南京 210002南京市江宁医院·南京医科大学附属江宁医院医学装备部 江苏 南京 211100中国人民解放军东部战区总医院秦淮医疗区医技保障科 江苏 南京 210002
信息技术与安全科学
手术机器人设备故障故障模式与影响分析预防性维护医疗设备管理
Surgical RobotEquipment FailureFailure Mode and Effects AnalysisPreventive MaintenanceMedical Equipment Management
《机器人外科学杂志(中英文)》 2026 (3)
492-497,6
江苏省自然科学基金(BK20181113) Natural Science Foundation of Jiangsu Province(BK20181113)
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