July 21, 2015 — A recent study (PDF) of adverse events submitted to the FDA has found nearly 150 deaths associated with the use of surgical robots.
Intuitive Surgical’s Da Vinci Surgical Robot hit the market in 2000 and has rapidly gained popularity in hospitals all over the United States. Between January 2000 and December 2014, the FDA received reports of 144 deaths and 1,391 patient injuries.
The FDA also received 9,061 reports of robotic malfunctions, resulting in hundreds of patient injuries. These reports included:
- Broken or burnt pieces of instruments falling into patients during surgery: 1,166 reports, contributing to 119 injuries and one death.
- Instrument electrical arcing: 193 injuries involving burned tissues or electrocutions.
- Instruments moving unintentionally: 52 injuries and one death
- Problems with system errors, video, or imaging: 41 injuries and one death
The authors of the study recommended implementing new safety measures:
“Despite widespread adoption of robotic systems for minimally invasive surgery, a non-negligible number of technical difficulties and complications are still being experienced during procedures. Adoption of advanced techniques in design and operation of robotic surgical systems may reduce these preventable incidents in the future.”
Robotic surgery is extremely expensive, has a steep learning curve, and introduces new risks in addition to the normal risks associated with surgery.
The percentage of robotic-assisted hysterectomies skyrocketed from 0.5% to nearly 10% between 2010 and 2013, but studies have not shown that they improve patient outcomes compared to existing minimally-invasive alternatives. In 2013, the American College of Obstetrics and Gynecology warned that “aggressive direct-to-consumer marketing of the latest medical technologies may mislead the public into believing that they are the best choice.”