Robotic Surgery Complications Extensively Underreported

A new study suggests that device-related robotic surgery complications reported to the US Food and Drug Administration (FDA) are grossly underreported.

Researchers at Johns Hopkins University (JHU; Baltimore, MD, USA) searched the FDA device-related complications database, LexisNexis, news media reports, and the public access to court electronic records (PACER) to identify robotic surgery-related complications over a 12-year period (January 1, 2000 to August 1, 2012). Cases from LexisNexis and PACER were cross-referenced with the FDA database to determine cases where FDA reports were inaccurate, filed late, or not filed.

The results showed that although more than one million robotic surgeries have been performed in the US since 2000, hospitals only reported 245 complications to the FDA during the study period, including 71 deaths and 174 nonfatal injuries; median time to report an event was 30 days. Eight cases were identified from the LexisNexis and PACER searches where FDA reports were improperly filed. In five of these, no report was filed within a mean follow-up of 4.1 years. In the three cases where a report was filed, the mean time between the event and the FDA report was almost two years.

While complications such as excessive bleeding were reported, there were other problems that may not have been reported correctly, or at all, the researchers speculated. For example, surgeons can accidentally cut the aorta during robotic surgery because they cannot feel how firm it is, but the data was unclear as to whether this would be reported as a surgeon- or device-related problem. They also cited a previous study in which nearly 57% of surgeons surveyed anonymously said that they had to convert to laparoscopic or open surgery after the robotic device malfunctioned; it is unclear how, or if, those errors are reported with the FDA. The study was published in the August 27, 2013, issue of the Journal for Healthcare Quality.

“The number reported is very low for any complex technology used over a million times. Decisions should not be made based on the information in the FDA database,” said study author associate professor of surgery Martin Makary, MD, of the JHU School of Medicine. “A broader roster of errors must be tracked as device-related problems. We need to be able to give patients answers to their questions about safety and how much risk is associated with the robot.”

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