da Vinci Robot Lawsuit

Thousands of patients have reported adverse side effects from using the da Vinci and other robotic surgical systems. These side effects include organ and blood vessel punctures, surgical burns, and death.

Bloomberg News reported that the Food and Drug Administration (FDA) asked surgeons at key hospitals to list the complications they may have seen with the machines, which cost about 1.5 million each and were used in almost 500,000 procedures in 2012.

According to CNBC, an "urgent medical device notification" was recently issued by the surgical robot maker, Intuitive Surgical. The notification alerts hospitals that a potential issue was identified with one of the robot's instruments. "Micro-cracks" in some models of Intuitive's monopolar curved scissors can cause leaks that "may create a pathway for electrosurgical energy to leak to tissue during use and potentially cause thermal injury."

The da Vinci Surgical System comprises a complex set of robotic arms and surgical instruments. Using 3-D images of the affected area, a doctor at a computerized console operates the system to perform high precision surgical procedures.

Since its release, da Vinci has demonstrated serious side effects, including:

Organ and blood vessel punctures
Internal burns and other heat injuries
Intestinal tears and burns
Organ and blood vessel tear and burn
Excessive bleeding
Severe bowel injuries
Repeat unnecessary surgeries
Death

The da Vinci robot’s other side effects include incontinence, vaginal cuff dehiscence, impotence, and cut ureters.

Medical systems provider Intuitive Surgical Inc. offered the da Vinci as a surgical platform to simplify delicate operations that require small incisions. Because of da Vinci’s side effects, by early 2013, there were at least nine U.S. lawsuits pending, alleging product defects and personal injuries, claims Citron, a financial market research firm. Plaintiffs are claiming, among other things, the da Vinci robot didn’t work as promised. Most of the injuries involved organ punctures or slashes; the second most common involved accidental electrical burns.

Thousands of Adverse da Vinci Side Effects Reported

Since the U.S. Food and Drug Administration (FDA) approved the da Vinci in 2000, patients have reported some 4,600 adverse events, claims Citron. Of those, 89 events included fatalities. Critics note the risks of using an expensive and difficult to operate da Vinci system outweigh whatever benefits the patients may see.

For the 600,000 women who annually require a hysterectomy, the best method is an operation through the vagina, stated Dr. James Breeden, president of the American College of Obstetricians and Gynecologists. Despite advertising that claims robotic surgery provides unique advantages, the reality is that a robot adds a minimum of $2,000 to the cost of a hysterectomy — without any improvement to the patient outcome. Also, he said surgeons must perform up to 90 robotic operations to become as proficient with this process as they are with other minimally invasive methods.