da Vinci Surgical System

In 2000, the FDA approved the da Vinci robot for use in certain types of surgeries. The new technology was intended to make smaller incisions, reduce bleeding, and speed up recovery time for patients, in addition to leaving smaller scars.

On May 4, 2010, however, the Wall Street Journal published an in-depth report on the da Vinci surgical system, indicating that some patients had experienced serious injuries related with its use. Since then, a growing number of patients have filed lawsuits against manufacturer Intuitive Surgical, claiming the company did not do enough to adequately warn about the health risks and robotic surgery complications.

What is the da Vinci robot?

The da Vinci surgical system is a robotic surgical device designed to make some surgeries easier and less invasive. Rather than use his or her own hands to perform the surgery, the surgeon uses the robotic “arms” and “hands” instead, which is intended to allow for more precise, controlled movements.

The da Vinci robot consists of the following parts:

1. Console: Ergonomically designed, the console is like the control panel of the system, where the surgeon sits while operating. From this console, the surgeon controls the movements of the robot.
2. Patient cart: Like an operating table, the patient cart is where the patient lays during the surgery.
3. Four robotic arms: These are the operating tools used to actually perform the operation on the patient—all controlled by the surgeon from the console. These are attached to the patient cart.
4. High-definition 3D vision system: This system delivers high-resolution video into the viewer located at the surgeon console. As the surgeon operates, the system displays high definition video in 3D for true perception of depth.
5. EndoWrist instruments: According to the manufacturer, these are designed with seven degrees of motion, which is a range of motion even greater than the human wrist. Each has a different specific task, such as clamping, suturing, and tissue manipulation.

What is the da Vinci robot used for?

The da Vinci robot has been used in the following types of procedures:

• Prostatectomies (prostate removal)
• Hysterectomies (removal of the uterus)
• Gastric bypasses
• Gall bladder removals
• Thyroid cancer surgeries
• Mitral valve prolapse
• Coronary artery disease
• Kidney cancer
• Colectomy (removal of cancerous tissue in the colon)
• Bladder surgery

What are the benefits of the da Vinci surgical system?

According to Intuitive Surgical’s website, the DaVinci robot allows major surgery to be performed “through the smallest of incisions,” with the following purported benefits:

• Significantly less pain
• Less blood loss
• Low rate of complications
• Less scarring
• Shorter hospital stay
• Faster return to normal daily activities
• Quick return of normal bodily functions
• Potential for better clinical outcomes

Potential complications with the da Vinci robot

Despite all the positive material put out by the manufacturer, some patients have reported less than desirable outcomes when going through surgery with the da Vinci robot. The Wall Street Journal reported that doctors at Wentworth-Douglass hospital in New Hampshire had operated on several patients with the device, and that one of these was so badly injured she required four more procedures to repair the damage. Two other patients suffered lacerated bladders. One woman who had her uterus accidentally cut during da Vinci robot surgery filed a lawsuit against Wentworth-Douglass and the two surgeons that operated on her.

In a March 2013 Bloomberg article, robosurgery was connected to at least 70 deaths since 2009.

Injuries that have been reported linked to the DaVinci surgical system include:

• Lacerated or perforated organs
• Damaged muscles
• Surgical burns
• Torn blood vessels
• Tears and/or burns of the intestines
• Cut ureters
• Severe bowel injuries
• Vaginal cuff dehiscence (separation of the vaginal incision—which may result in abdominal or pelvic contents being expelled through the vaginal opening)

Studies question wisdom of using da Vinci robot

In 2009, researchers reported on two cases of vaginal cuff dehiscence that had occurred after robotic total laparoscopic hysterectomy. The complication is rare, but can be very serious. The two women came back 7-8 weeks after surgery with abdominal pain and vaginal pressure. In both, the small bowel had protruded into the vagina through the separation of the vaginal incision. Both had to go through additional corrective surgeries. The researchers warned that vaginal cuff dehiscence may be occurring more frequently with robotic hysterectomies.

Other studies on the daVinci surgical system include:

• In March 2012, the Journal of Clinical Oncology published a study comparing traditional laparoscopic hysterectomy and robotic hysterectomy for endometrial cancer. They reported that despite claims of decreased complications with robotic hysterectomy, their results showed similar outcomes, including morbidity. Yet the robotic surgery cost more.
• Another 2012 article in the same journal noted that unlike new drugs, which require clinical trials and FDA approval, surgical innovations “are often developed and adopted with less stringent requirements to demonstrate their benefits, risks, and incremental costs.”
• In January 2012, researchers published a study in the same journal comparing the risks of problems with continence and sexual function following either robotic-assisted prostatectomy or open radical prostatectomy among men with prostate cancer. Results showed that risks of problems with continence and sexual function are high after both procedures—with no additional benefit found with the robotic procedure.
• A 2013 study published in JAMA concluded that robotic procedures have higher costs with little added benefit.

In March 2012, the American Congress of Obstetricians and Gynecologists issued a statement stating, “While there may be some advantages to the use of robotics in complex hysterectomies, especially for cancer operations…studies have shown that adding this expensive technology for routine surgical care does not improve patient outcomes. Consequently, there is no good data proving that robotic hysterectomy is even as good as—let alone better than—existing, and far less costly, minimally invasive alternatives.”

The FDA has stated that it is surveying hospitals on complications, outcomes, and dangers associated with the da Vinci robot, in response to an increase in adverse event reports, including organ damage and device failure.

Filing a da Vinci robot lawsuit

Patients who have been injured by the da Vinci robot may claim the device is defective, or that the manufacturer failed to provide adequate warnings about the risks. One da Vinci robot lawsuit, for example, was recently settled for an undisclosed amount. A Louisiana woman allegedly suffered severe complications after a DaVinci surgical system thyroid procedure. Other lawsuits raising similar allegations are pending throughout the country.