A national database keeps up with reports of injuries and deaths related to robotic surgeries across the United States, including Colorado. However, not every surgical error is being reported to the database, leaving the potential risks of robotic surgeries unclear for patients.
Although reports of injuries and deaths are sent to the Food and Drug Administration, it does not have the power to force doctors to send reports. Hospitals, however, are supposed to send reports, but they do not always do so. On top of this, reports of injuries or deaths happening during robotic surgeries do not always mean that the injuries or deaths were caused by robotic devices.
The inspector general of the Department of Health and Human Services has reported that the number of incidents that hospitals report is low. In 2003, at least one report was filed by 823 hospitals, but this number fell 37 percent to just 519 hospitals in 2007. Additionally, a 2006 report from the FDA estimated that only 15 percent of the 1.1 incidents associated with medical devices in 2003 were reported.
As of Nov. 3, 2013, the FDA received 3,697 reports about malfunctions, injuries and deaths related to robotic surgeries. This number increased from 2012, during which 1,595 reports were made. However, this does not mean that there were more incidents in 2013 than 2012. Some of the increase could be due to media attention, robotic equipment recalls or simply the fact that more robotic devices are being used.
Patients who are injured due to a surgical mistake may be entitled to compensation through medical malpractice liability. The parties held liable for the mistakes are often determined through a system of standards and tests.
Source: Bloomberg, "Unreported Robot Surgery Injuries Open Questions for FDA", Robert Langreth, December 29, 2013