Intuitive Surgical, Inc.

Headquartered in Sunnyvale California, Intuitive Surgical, Inc. was founded in 1995 and is considered a pioneer in global technology for minimally invasive robotic-assisted surgery. The company designs, manufactures and markets da Vinci surgical systems and accompanying accessories. At present, Intuitive markets the da Vinci robot within the United States via direct sales to hospitals. The corporation also has operations headquartered in Aubonne, Switzerland and Shanghai, China. Da Vinci surgical system sales are performed directly in some European countries, while Intuitive relies on distributors and agents throughout the rest of the world.

According to the Intuitive corporate profile, the company has more than 2,362 employees worldwide and reported a net worth of $2.9 billion in 2012 – consisting of investments, cash and cash equivalents. On July 18, 2013, Reuters reported that Intuitive shares plummeted 11 percent after the company slashed its yearly sales forecast due to a lackluster demand for its da Vinci surgical system. Between a recent FDA warning following a June inspection of its facilities and at least 26 pending lawsuits alleging da Vinci robotic surgery complications, Intuitive has generated a great deal of negative press as of late.

The company’s swift ascension has slowed amid mounting litigation and several Class II da Vinci component recalls. Intuitive said that it now anticipates 2013 revenues to fall somewhere between flat and 7 percent higher. The company had previously predicted a 16 to 19 percent growth within the time span.

Intuitive da Vinci robot originations

The government’s DARPA (Defense Advanced Research Projects Agency) project – used to develop robotic technology for use on the battlefield –  inspired the creation of the first da Vinci robot. The computer-enhanced system introduces a computer console and 3DHD vision system between the surgeon’s eyes, hands and micro-instruments, allowing for more precise surgical applications using smaller incisions. Though labeled a robot, the system is not autonomous and cannot perform any tasks or movements without the surgeon’s direct input via the hand controls.

The FDA cleared the Intuitive da Vinci robot in 2000.

As reported in the New York Times, before the FDA cleared the da Vinci robot, federal regulators required more information as to how surgeons would be trained on the high-tech system. Intuitive gave the FDA a 70-item test and explained that all doctors would participate in a thorough three-day training program. Two years later, however, Intuitive had overhauled their training requirements, swapping the 70-item exam with an online 10-question quiz and cutting the hands-on training protocol to one day at the company’s facilities.

Products and patents held by Intuitive Surgical

By 2012, an estimated 2,024 hospitals worldwide had at least one da Vinci robot installed, bringing the total to 2,585 da Vinci systems in use. A da Vinci robotic system costs between $1.5 and $2.5 million, depending on the local market and the system’s configuration. Intuitive Surgical, Inc. maintains exclusive rights to over 1,150 American-based and foreign patent applications as of December 31, 2012.

Intuitive holds patents and patent applications for components of the da Vinci surgical system including:

• surgeon console
• electromechanical arms
• vision system
• endoscope positioning system
• EndoWrist instruments

In addition to being utilized in U.S. hospitals, the da Vinci surgical system is used in the following countries: Austria, Belgium, Bulgaria, Cypress, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Italy, The Netherlands, Norway, Romania, Spain, Sweden, Switzerland, Turkey, United Kingdom, Canada, China, India, Japan, Malaysia, Singapore, South Korea, Thailand, Taiwan, Israel, Pakistan, Qatar, Saudi Arabia, Australia, New Zealand, Argentina, Brazil, Chile, Columbia, Venezuela, Mexico, Puerto Rico, and Russia.

FDA investigation and Da Vinci surgery complications

Approximately 450,000 da Vinci robotic procedures were performed in 2012 – almost triple the amount performed four years prior. Intuitive, first lauded for its advanced breakthrough in minimally invasive surgery is now facing legal allegations regarding its safety testing and doctor training programs. The FDA is also looking into an increase in adverse event reports during da Vinci robotic surgeries.

In early 2013, federal regulators began surveying doctors who used the system. While such surveys are generally routine, FDA spokesperson Synim Rivers confirmed the basis for the investigation “is the increase in number of reports received” about the da Vinci robot.

Robot injuries and deaths prompt lawsuits against Intuitive

Serious bowel injuries, torn blood vessels, surgical burns and punctured organs are just some of injuries alleged by patients who have filed an Intuitive Surgical lawsuit. Some patients who opted for robotic-assisted surgery fared even worse. Bronx resident Gilmore McCalla filed a lawsuit against Intuitive, claiming surgical burns during a da Vinci hysterectomy caused his daughter’s untimely death just two weeks later.

Lauren Burch, an Intuitive Surgical, Inc. spokesperson said that the company couldn’t comment on pending litigation but stands behind the safety of the da Vinci surgical system. In an April 19 filing with the U.S. Securities and Exchange Commission (SEC), Intuitive confirmed that it was named as defendant in 26 lawsuits, and had reached tolling agreements in some of the complaints, which could facilitate out-of-court da Vinci robot settlements without going to court.