Indiana University Medical Center, Indianapolis, USA.
BJU Int. 2012 Apr;109(8):1222-7; discussion 1227. doi: 10.1111/j.1464-410X.2011.10692.x. Epub 2011 Nov 1.
To assess annual rates of robotic system malfunctions and compare the da Vinci S(®) system (dVS) and da Vinci(®) surgical system (dV). To assess the types of malfunctions and associated outcomes for robotic cases and determine the extent to which experience and technological improvements impact these.
This study is a retrospective review of the US Food and Drug Administration (FDA) MAUDE (Manufacturer and User Facility Device Experience) database, a publicly available, voluntary reporting system (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm). The database was searched using the two phrases 'da Vinci' and 'Intuitive Surgical' from 2003 to 2009. Malfunctions of the instruments, console, patient-side cart, camera and cannula were recorded. Data on intraoperative injuries, case delays and conversions were also collected.
In all, 1914 reports were reviewed (991 dVS and 878 dV, 45 unclassified) with peak years for reports of 2008 for dVS (571) and 2007 for dV (211), P < 0.001. With respect to time, the proportion of console and patient-side cart malfunctions declined from 2007 onward compared with the proportions prior to 2007 (5.1% vs 9.4% and 6.6% vs 10.9%). Patient injury did not change with year of surgery (0.5-5.4% of malfunctions, P= 0.358), open conversions declined (21.3% of malfunctions before 2007 vs 9.9% from 2007 onward, P < 0.001) and patient deaths increased (0.0013% of cases before 2007 vs 0.0061% of cases from 2007 onward, P < 0.001). With regard to robotic system, console and patient-side cart malfunctions were more frequent with the dV than the dVS: 82/878 vs 39/991 and 100/878 vs 48/991, P < 0.001. Open conversion was more frequent with dV than dVS (19.3% vs 7.7% of reported malfunctions, P < 0.001), while patient injury was less with dV than dVS (3.5% vs 5.9%, P= 0.021).
The dVS decreased console and patient-side cart errors relative to total malfunctions, which were also influenced by surgical year. Open conversions were reduced by increased robotic experience and newer surgical system. Differences in patient injury may reflect changes in reporting or case complexity.
评估机器人系统故障的年发生率，并比较达芬奇 S（®）系统（dVS）和达芬奇（®）手术系统（dV）。评估机器人手术中故障的类型和相关结果，并确定经验和技术改进在多大程度上影响这些故障。
本研究是对美国食品和药物管理局（FDA）MAUDE（制造商和用户设施设备经验）数据库的回顾性分析，该数据库是一个公开的、自愿报告系统（http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm）。从 2003 年到 2009 年，使用“da Vinci”和“直觉外科(Intuitive Surgical)”这两个短语对数据库进行了搜索。记录了器械、控制台、患者侧台车、相机和套管的故障情况。还收集了术中损伤、手术延迟和转换的数据。
共回顾了 1914 份报告（991 份 dVS 和 878 份 dV，45 份未分类），dVS 报告的高峰年份为 2008 年（571 份），dV 为 2007 年（211 份），P<0.001。就时间而言，与 2007 年之前相比，控制台和患者侧台车故障的比例从 2007 年开始下降（5.1%比 9.4%和 6.6%比 10.9%）。患者损伤与手术年份无关（5.1%的故障为 0.5-5.4%，P=0.358），开放性转换减少（2007 年之前的故障为 21.3%，2007 年以后的故障为 9.9%，P<0.001），患者死亡增加（2007 年之前的病例为 0.0013%，2007 年以后的病例为 0.0061%，P<0.001）。关于机器人系统，dV 的控制台和患者侧台车故障比 dVS 更频繁：82/878 比 39/991 和 100/878 比 48/991，P<0.001。dV 的开放性转换比 dVS 更频繁（报告的故障中的 19.3%比 7.7%，P<0.001），而 dV 的患者损伤比 dVS 更少（3.5%比 5.9%，P=0.021）。
dVS 相对于总故障减少了控制台和患者侧台车的错误，这也受到手术年份的影响。随着机器人经验的增加和新的手术系统的应用，开放性转换减少。患者损伤的差异可能反映了报告或病例复杂性的变化。
