Intuitive Surgical, Inc.

The U.S. has long been a global leader in the medical device industry, which is responsible for employing about 2.4 million Americans. In an industry in which 80 percent of all companies are considered small to medium businesses that employ 50 or fewer people, Intuitive Surgical, Inc. has devoured a lion’s share of the market.

Intuitive, which has headquarters in Sunnyvale, California, is considered the industry leader in surgical robotics. The company created the popular da Vinci surgical system, which allows for minimally invasive surgeries via a surgeon-controlled robotic device. According to the company, about 2,025 hospitals around the world had installed about 2,585 da Vinci robots by December 31, 2012. Since that time, however, the medical device company has been the target of complaints by some patients about significant and even life-threatening complications incurred as a result of robotic surgery.

Company overview

Intuitive Surgical, Inc. employs more than 2,362 individuals globally. The company reported that its fiscal year 2012 revenue was $2.8 billion, which represents a 24 percent increase over 2011. For 2012, the company reported 2.9 billion in cash, cash equivalents, and investments, which represents a 34 percent increase over 2011.

In a statement released to investors on January 14, 2014, the company announced an anticipated 2013 fourth quarter revenue of about $576 million, which is approximately a five percent drop from the $609 million for the fourth quarter of 2012. The preliminary fourth quarter revenue from instruments and accessories alone was expected to increase by about six percent. However, the company’s report noted that although the da Vinci robot drove the 2013 instrument and accessories growth, the figures were “partially offset by a reduction in stocking orders related to a decline in system sales.”

In fact, preliminary data for the fourth quarter of 2013 for the da Vinci robotic surgical systems alone were expected to decline by about 23 percent, representing a decrease from $265 million to $205 million. For the full year, revenue from da Vinci was expected to decline by 11 percent. The company sold just 138 da Vinci surgical systems during the fourth quarter of 2013, as compared to 175 robotic systems throughout the fourth quarter of 2012. The company explained the decline by noting “moderating procedure growth in benign gynecology, combined with changing hospital capital spending priorities.” However, it is also possible that the growing number of patients who have filed an Intuitive surgical lawsuit may have been partially responsible for the decline in revenue.

Development of the da Vinci system

The original prototype for the da Vinci surgical system was developed at the Stanford Research Institute in the 1980s through a contract with the U.S. Army. Originally, the robot was intended to perform battlefield surgery; however, developers were attracted to the idea of commercial development. Intuitive Surgical, Inc. was born of this idea. Founded in 1995, the company developed their system by 1999 and had it cleared by the FDA in 2000 for general laparoscopic surgery.

During surgery, the system is always manipulated by a surgeon; it does not operate autonomously. During subsequent years, the FDA cleared the device for use in additional procedures.

The da Vinci robot surgery system is approved to perform the following kinds of procedures:

• Thoracoscopic
• Urologic
• Gynecologic
• Pediatric
• Cardiac
• Transoral otolaryngology

The company completed an initial public offering (IPO) in 2000, followed by a second IPO in 2003.

By 2011, the da Vinci system was being used in four out of every five radical prostatectomies. It became the leading option for minimally invasive surgery. In 2012, surgeons performed about 450,000 da Vinci surgeries worldwide, a 25 percent increase from the previous year.

Intuitive touts clinical evidence

The company website lists the growing numbers of clinical trials that involved the da Vinci system. The company touts the system as being a safer alternative to traditional laparoscopic surgery, with fewer complications, infections, reduced recovery times, reduced need for post-operative nursing home care, and improved post-operative pain management.

According to the latest available data, more than 7,000 peer-reviewed clinical studies regarding this system have appeared since 1998. However, the company makes no mention of the number of peer-reviewed studies that have demonstrated adverse events associated with the robotic surgery system.

Spike in adverse events

In January 2013, the FDA began investigating the da Vinci surgical system after adverse event reports (AERs) spiked. In 2011, of the 292,000 robotic surgeries performed in the U.S., the FDA received 211 AERs. By 2012, that number had risen to 282 AERs. The FDA conducted interviews with surgeons who used the da Vinci system, questioning them about such critical factors as patient selection, equipment repairs, user training, and complications as compared to conventional surgeries.

Many of the AERs involved equipment failures. The company had begun reporting device malfunctions, including cable breaks, by September 2012. Other reports involved severed nerves, punctured bladders, and severed blood vessels.

According to a report by Medscape, “In other cases, the da Vinci surgical robot seemed to have a life of its own, at times inexplicably cauterizing a fallopian tube, damaging heart tissue, or refusing to let go of a patient’s tissue with its grasper.”

The most commonly reported injuries from the da Vinci system are burns, which are caused by electricity from the device. Some patients have suffered perforated colons or intestines, and at least one patient has experienced the sudden migration of her intestines through her vagina and out of her body. This last patient, a California resident, filed a lawsuit against Intuitive Surgical.

In 2012, the family of Juan Fernandez was awarded $7.5 million after the Chicago resident died after robotic spleen surgery. The death was attributed to punctured intestines, causing an infection that took his life. During that same year, at least five deaths were blamed on the da Vinci system, including a woman who underwent a robotic hysterectomy.

Company issued recalls

As a result of the potential for serious complications, Intuitive Surgical, Inc. has issued multiple Class II recalls relating to the device, including a recall issued in December 2013. This recall was said to have affected about 1,400 of da Vinci systems worldwide. The recall notice acknowledged problems with the movements of system components. The company noted that the robotic surgical system may temporarily stall, which can put patients in danger.

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