Adverse Events in Robotic Surgery: A Retrospective Study of 14 Years of FDA Data

The adverse events reports related to robotic surgical systems and instruments, submitted to the publicly available FDA MAUDE database between January 2000 and December 2013.We extracted this data by searching the MAUDE records which are available on the FDA website at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/ReportingAdverseEvents/ucm127891.htmThe structured data generated by our natural language parsing tool, after analysis of unstructured fields in the FDA MAUDE records. The new information (fields) extracted from the data include: • Patient injury (such as burns, cuts, or damage to organs) and death events that were reported under another Event Type, such as “Malfunction” or “Other”. • Surgical specialty and type of robotic procedure during which the adverse events occurred. • Major types of device or instrument malfunctions (e.g., falling of burnt/broken pieces of instruments into patients’ bodies or electrical arcing of instruments) • Adverse events that caused an interruption in the progress of surgery, by leading the surgical team to troubleshoot technical problems (e.g., restarting the system), convert the procedure to non-robotic surgical approaches (e.g., laparoscopy or open surgery), or abort the procedure and reschedule it to a later time.

涉及机器人手术系统和器械的不利事件报告，这些报告提交至公开可查的FDA MAUDE数据库，时间跨度为2000年1月至2013年12月。通过检索位于美国食品药品监督管理局（FDA）网站上的MAUDE记录（http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/ReportingAdverseEvents/ucm127891.htm），我们提取了这些数据。利用我们的自然语言解析工具对FDA MAUDE记录中的非结构化字段进行分析后，生成了结构化数据。从数据中提取的新信息（字段）包括：• 患者受伤（如烧伤、切割或器官损伤）及死亡事件，这些事件在其他事件类型下被报告，例如“故障”或“其他”。• 在发生不利事件的手术专业领域及机器人手术类型。• 设备或器械的主要故障类型（例如，器械烧毁或破碎的部件落入患者体内或器械的电弧放电）。• 导致手术进程中断的不利事件，这些事件通过引导手术团队解决技术问题（例如，重新启动系统）、将手术过程转换为非机器人手术方法（例如，腹腔镜或开腹手术）或中止手术并重新安排手术时间。