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

2016-03-08T16:22:05Z (GMT) by Homa Alemzadeh
<table><tbody><tr><td>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.<br>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<br><br>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: <br>• 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”. <br>• Surgical specialty and type of robotic procedure during which the adverse events occurred. <br>• Major types of device or instrument malfunctions (e.g., falling of burnt/broken pieces of instruments into patients’ bodies or electrical arcing of instruments) <br>• 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.</td><td><br></td></tr></tbody></table>