Da Vinci Surgery Problems

The da Vinci robot was first approved for laparoscopic surgery in 2000. It was advertised as “the latest technological breakthrough” to reduce complications caused by human error. The use of robotic surgical systems in American surgery suites has grown 75 percent from 2007 to 2011, with about 400,000 robot-assisted procedures performed annually; but there may be more problems with these medical devices than patients and their surgeons realize.

In 2013, a study published in the Journal for Healthcare Quality found that 245 robotic surgery problems – including 71 deaths and 174 nonfatal injuries — were reported to the FDA. They also discovered eight cases where reporting was insufficient and five cases where no FDA report was filed at all, despite obvious robotic surgery failure.

In one 2009 case, a person died during robotic surgery, but the report was not filed until 2010 after the Wall Street Journal broke the story. The study concluded that it’s essential for da Vinci surgery problems to be “uniformly captured, reported and evaluated” so the “safety of the new technology” can be determined.

Reports of robotic surgery complications

Burns, tears, organ punctures, internal bleeding and infection are some of the complaints associated with the da Vinci robot. Arteries, blood vessels, bowels, bladders, vaginal cuffs, urinary tracts, kidneys and other tissues have been damaged by robot malfunction.

The official “cause of death” in 71 reported da Vinci robot-related cases was listed as:

• Hemorrhage in 21 cases
• Infection in 10 cases
• Cardiac arrest in 9 cases
• Multi-organ failure in 5 cases, and
• Pulmonary embolus in 2 cases.

There were also one case each for bilateral tension, pneumothorax, ischemic stroke, narcotic overdose and necrotizing fasciitis. Twenty cases were not reported with a specific cause of death.

According to the NY Daily News, stories of da Vinci surgery problems include:

• A woman who died after a surgeon-operated robot nicked a blood vessel during a 2012 hysterectomy.
• A Chicago man who died after spleen surgery in 2007.
• A New York man whose colon was perforated during prostate surgery.
• A robot arm that wouldn’t let go of tissue grasped during colorectal surgery.
• A robot arm that accidentally hit a patient’s face during a hysterectomy.

Preventable burns & other problems linked with da Vinci surgery

Heat-related injuries, including serious burns, are concerns most commonly associated with the da Vinci robot. CNBC News reports that serious burns may occur when sparks emit from the robot, causing damage just beyond the internal camera’s field of vision. These sparks were believed to be caused by “microscopic cracks” in the insulated covers that are meant to protect the tools.

In 2012, Intuitive Surgical issued a voluntary recall to replace the tip covers for the scissors even though they said the “probability of serious adverse health consequences is remote.” They sent notification to consumers to alert them about new instructions for the use of insulated tip covers.

During its inspection of the Intuitive Surgical’s HQ facilities located in Sunnyvale, California, the FDA discovered four distinct field actions taken to lower the risk posed by the device. Yet, FDA inspectors issued a warning letter, stating that the company hadn’t officially reported certain safety changes to their system and asking for “additional corrective actions.”

While the company stated it planned to comply with FDA requirements, it’s unclear whether this is enough to save the company from the dozens of da Vinci robotic surgery lawsuits filed against them.

Surgical procedures linked to highest risk

According to Business Insider, of the 71 deaths…

• 22 occurred during gynecologic procedures
• 15 occurred during urologic procedures
• 12 occurred during cardiothoracic procedures
• 10 occurred during head and neck surgery
• 3 occurred during colon/rectum surgery, and
• 3 occurred during general surgery.

The Da Vinci surgical robot is not recommended for:

• Hysterectomies – A Journal of the American Medical Association study found that robotic surgeries added $2,000 to the cost of the procedure, with no significant clinical advantages in pain, healing time or reducing complications compared to laparoscopic surgery. Intuitive Surgical states that the results should be compared to open surgeries, rather than other minimally-invasive techniques. However, a 2011 analysis published in the American Journal of Obstetrics & Gynecology reported double the complication rate with robotic surgery compared to traditional surgery.
• Thyroidectomies – Intuitive Surgical was reprimanded by the FDA in March 2013 for failing in its duty to tell hospitals and other healthcare facilities that the da Vinci robot has never been approved by the FDA for use in thyroidectomy procedures.
• Prostate, Kidney & Bladder Surgeries – One in 15 people undergoing these surgeries develops a nerve injury related to pressure from their positioning on the operating table, according to a study of 334 patients published in The Journal of Urology. This injury included weakness, numbness or immobility in the hands or feet. MSN News reports that half of the injuries resolved within a month, but five injuries lasted more than six months, prompting the FDA to take a closer look into Intuitive Surgical safety reports.

Robotic surgery complications lead to lawsuits

Bloomberg News reports that Intuitive Surgical is defending at least 50 product liability lawsuits.

Several of the cases involving da Vinci surgery problems have reached resolution:

• $7.5 million jury award: Juan Fernandez’s family won their case after a poorly-trained surgeon accidentally punctured their loved one’s intestines, causing his death, during robotic spleen surgery.
• Undisclosed settlement: Complications during a thyroid procedure led to the need for open surgery and a large scar for a Louisiana woman. Intuitive Surgical settled the claim before it could appear in court.
• Undisclosed settlement: A 2010 robot-assisted hysterectomy led to a painful abscess and secondary surgery for Patricia Mayfield of Alabama. The lawsuit was settled quietly for an undisclosed sum.

In one case, a jury voted 10-2 in favor of Intuitive Surgical after the death of a 67-year-old patient who experienced sepsis, damage to his kidney and lungs, and stroke 4 years following robot-assisted surgery. The judge ruled that the man’s previously existing health conditions, including being obese and having undergone a hernia operation, made him an unfit candidate for the surgery.

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