Debate Over The Safety of the Da Vinci Robotic Surgical Device

Posted on

Many surgeons are turning to robots to conduct certain surgical operations, prompting a spike in the number of such procedures carried out every year.  But a recent uptick in potentially injurious incidents associated with the devices has led to a debate over the safety and efficacy of the technology.

At the center of the debate is the da Vinci Surgical System from Intuitive Surgical, a company based in Sunnyvale, California.  Since its inception, the da Vinci has experienced a surge in popularity thanks to the perceived benefits of the device.  Proponents argue that bleeding events are rarer and the threat of something like a shaking hand is made moot.  This could be why around a quarter of American hospitals have at least one machine and why surgeries involving the da Vinci jumped to 387,000 last year, up from 114,000 four years prior.

However, the FDA has started querying surgeons about their experience with the da Vinci following an increase in adversity reports.  Although Intuitive Surgical argues that an alteration to the way incidents have been reported has led to the increase, but some doctors argue that more studies have to be conducted to truly determine the adequacy of the device.

A paper put together in part by a surgeon with Johns Hopkins alleges that incidents involving the da Vinci have gone largely unreported and that widespread adoption of the device owes more to marketing than to patient benefit.  That same author also conducted a 2011 study which found that many hospital websites extolling the virtues of the da Vinci contained claims that could be deemed unproven or misleading.

Since 2012 began, an estimated 500 adverse event reports have been filed with the FDA, although some were duplicates.  One situation found the robotic arm refusing to let go of human tissue, prompting a full device shutdown, while another involved a robotic arm striking a woman in the face, leading the overseeing surgeon to completely rethink the operation.

Time will tell what the FDA’s inquiry turns up, but in the meantime, patients should make sure to discuss surgical options with a doctor to find out what treatments are right for them or if they’re privy to potential risks.