Adverse Events in Robotic Surgery: A Retrospective Study of 14 Years of FDA Data
datasetposted on 08.03.2016, 16:22 authored by Homa AlemzadehHoma Alemzadeh
|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.htm
The 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.