Da Vinci Robotic Surgery Complications

To patients, Da Vinci robotic surgery sounds like a dream come true. When Michelle Zarick complained to her doctor about excessive vaginal bleeding, Da Vinci was presented as “the latest, greatest” technique available. She recalls, “In my mind, there was no alternative but to use this fabulous technology.” However, five weeks after her life-changing surgery, Zarick heard a “pop” and saw her intestines protruding from her body.  Bloomberg News reports that Da Vinci robotic surgery complications include 115 reports of DaVinci surgery problems in 2012 — and approximately 70 deaths since 2009.

Reported DaVinci surgery problems include:

• Burns
• Tears
• Organ punctures and damage
• Internal bleeding
• Abnormal organ / vessel connections
• Sepsis / infections

Da Vinci robotic surgery complications may damage arteries, blood vessels, bowels, bladder, vaginal cuff, the urinary tract, kidneys, as well as other surrounding tissues and organs.

Da Vinci robotic surgery complications: burns and organ damage

Burns and heat-related damage to the intestines, ureter, bowel, bladder, and other organs are some of the most common complaints against the Da Vinci robot. Dr. Francois Blaudeau, a practicing Alabama gynecologist and attorney representing Da Vinci injury lawsuits, told CNBC News that the burns occur due to the company’s use of monopolar energy, which can cause sparks that damage the surrounding organs. Monopolar energy instruments are also used by human surgeons, but Dr. Blaudeau explains that there is a portion of the robotic arm that extends beyond the camera’s field of vision, so there is more likelihood that sparks will not be seen by the human guiding the machine. NBC News adds that some of the damages occurred due to “microscopic cracks in the protective covers” that insulate the tools.

Da Vinci surgery complications: internal bleeding

CNBC also told the story of 24-year-old Kimberly McCalla, who went in for a routine hysterectomy but wound up with a laceration to her main artery during robot-assisted surgery. “Blood was flowing from her leg, from between her legs,” her father, Gilmore McCalla, told the news organization. “And two nurses were there around her, catching the blood with a bottle.” She died 13 days after the initial surgery and the family has filed a da Vinci robot lawsuit against Intuitive Surgical. The suit contends that the tool was not properly insulated, which allowed electrical burns to surrounding tissue.

Are DaVinci surgery problems preventable?

Evidence suggests that the manufacturer is aware of adverse events associated with the Da Vinci robot and have been taking internal steps to fix the problems. However, it’s questionable whether their efforts have been successful or not. An FDA inspection of the Intuitive Surgical headquarters in Sunnyvale, California this past spring found that the company has taken four separate “field actions” designed to “reduce the risk to health posed by a device.” They sent notification to customers – but not the FDA – to alert them about new instructions for using insulating tip covers. A company letter suggested that one of the causes for injurious electrical arcing is defective cannulas used to insert instruments into the body.

Which procedures are at risk for complications?

About 367,000 DaVinci robot procedures are done each year, according to Bloomberg News. Robotic surgery offers advantages over conventional surgery for head and neck cancer patients, rectal surgery candidates and stomach shrinking / kidney transplant operations, reports the NY Daily News.

The Da Vinci robot is  not recommended for: 

• Hysterectomies – More than half of all robot-assisted procedures are gynecological treatments like hysterectomies. In 2011, analysis published in the American Journal of Obstetrics & Gynecology found that complications occur in 2% of robot hysterectomies – which is twice the rate seen in conventional surgery. Dr. James Breeden, president of the American College of Obstetricians and Gynecologists, told Fox News, “It is important to separate the marketing hype from the reality when considering the best surgical approach,” Breeden said, adding: “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.”
• Thyroidectomies – The March 30 FDA report cited Intuitive Surgical for failing to tell customers that the Da Vinci robot is not FDA-approved for use in thyroidectomy surgeries or for pediatric patients.

Plaintiffs who have filed DaVinci robot lawsuits

So far, at least 25 da Vinci robot lawsuits have been filed against Intuitive Surgical and some of those cases have been resolved.

• The family of Chicago resident Juan Fernandez successfully won a malpractice suit after the death of their loved one in 2007. The lawsuit alleged that poorly-trained surgeons accidentally punctured the man’s intestines, causing a fatal infection during robotic spleen surgery. The jury awarded the relatives $7.5 million, according to the NY Daily News.
• Washington resident, 67-year-old Fred Taylor, underwent a five-hour robot-assisted surgery, which turned into a 13-hour ordeal. He died of kidney and lung damage, sepsis and stroke four years after the operation. It was his surgeon’s first time using the DaVinci robot and did not realize that Mr. Taylor’s obesity and previous hernia operation made him an unfit candidate for robot-assisted surgery. His family sought damages, but the Washington jury voted 10-2 in favor of Intuitive Surgical.
• This past March, a Louisiana woman suffered Da Vinci robotic surgery complications following a thyroid procedure. The robot’s malfunctioning forced her surgeon to default to a more invasive procedure that left a large scar. Intuitive Surgical agreed to settle the claim for an undisclosed amount.
• Patricia Mayfield of Alabama allegedly developed a painful abscess requiring corrective surgery after a daVinci hysterectomy in 2010. Again, Intuitive Surgical negotiated a da Vinci lawsuit settlement, the terms of which are confidential.