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Instrument Failures for the da Vinci Surgical System: A Food and Drug Administration MAUDE Database Study

机译：达芬奇手术系统的仪器故障：美国食品药品监督管理局MAUDE数据库研究

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Background: Our goal was to analyze reported instances of the da Vinci robotic surgical system instrument failures using the FDA's MAUDE (Manufacturer and User Facility Device Experience) database. From these data we identified some root causes of failures as well as trends that may assist surgeons and users of the robotic technology. Methods: We conducted a survey of the MAUDE database and tallied robotic instrument failures that occurred between January 2009 and December 2010. We categorized failures into five main groups (cautery, shaft, wrist or tool tip, cable, and control housing) based on technical differences in instrument design and function. Results: A total of 565 instrument failures were documented through 528 reports. The majority of failures (285) were of the instrument's wrist or tool tip. Cautery problems comprised 174 failures, 76 were shaft failures, 29 were cable failures, and 7 were control housing failures. Of the reports, 10 had no discernible failure mode and 49 exhibited multiple failures. Conclusions: The data show that a number of robotic instrument failures occurred in a short period of time. In reality, many instrument failures may go unreported, thus a true failure rate cannot be determined from these data. However, education of hospital administrators, operating room staff, surgeons, and patients should be incorporated into discussions regarding the introduction and utilization of robotic technology. We recommend institutions incorporate standard failure reporting policies so that the community of robotic surgery companies and surgeons can improve on existing technologies for optimal patient safety and outcomes.
机译：背景：我们的目标是使用FDA的MAUDE（制造商和用户设施设备体验）数据库来分析达芬奇机器人手术系统仪器故障的报告实例。从这些数据中，我们确定了一些故障的根本原因以及可能有助于外科医生和机器人技术使用者的趋势。方法：我们对MAUDE数据库进行了调查，并统计了2009年1月至2010年12月之间发生的机器人仪器故障。我们根据技术将故障分为五个主要类别（陶瓷，轴，手腕或工具尖端，电缆和控制箱）。仪器设计和功能上的差异。结果：通过528个报告记录了总共565个仪器故障。大多数故障（285）是由于仪器的手腕或工具尖端造成的。谨慎问题包括174个故障，76个是轴故障，29个是电缆故障，还有7个是控制外壳故障。在这些报告中，有10个没有明显的故障模式，有49个出现了多个故障。结论：数据表明，在短时间内发生了许多机器人仪器故障。实际上，许多仪器故障可能不会报告，因此无法从这些数据确定真正的故障率。但是，应将医院管理人员，手术室工作人员，外科医生和患者的教育纳入有关引入和利用机器人技术的讨论中。我们建议机构采用标准的故障报告政策，以便机器人手术公司和外科医生社区可以改进现有技术，以实现最佳的患者安全性和结果。

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