July 21, 2015 — Nearly 150 deaths and over 1,000 injuries have been linked to surgical robots over a 14-year period in the United States, according to a new study.
Researchers looked at adverse events submitted to the FDA between January 2000 and December 2013. During that time, there were 144 deaths, 1,391 patient injuries, and 9,061 device malfunctions.
Device and instrument malfunctions included:
- Falling of burnt/broken pieces of instruments into the patient: 1,166 reports, which contributed to 119 injuries and one death
- Electrical arcing of instruments: 193 injuries, including the burning of body tissues and electrocutions
- Unintended operation of instruments: 52 injuries and one death
- System errors and video/imaging problems: 41 injuries and one death
Authors of the study (PDF) called for 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.”
Robot surgery is marketed as a way to improve patient outcomes, but many experts have questioned these claims. The robots are extremely expensive, have a steep learning curve, and have unique risks in addition to the normal risks of surgery.
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,” and cautioned that there is no data proving that robotic hysterectomies are better than existing, less costly, minimally-invasive alternatives.