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Urgent Medical Notification Issued Over da Vinci Surgical Robot System

May 11, 2013

The maker of the da Vinci robotic surgical system, Intuitive Surgical Inc., just issued an “urgent medical notification” on one of the device’s components.

The “potential issue” involves one of the robotic arms and a defect which could burn patients’ organs during surgery, according to StreetInsider.

The da Vinci is the only robotic surgery device that has received U.S. Food and Drug Administration (FDA) approval for soft tissue surgeries, including prostate and gallbladder removal, hysterectomies, cardiac repair, stomach reduction, and organ transplantation. Similar systems have received regulatory approval, but for neurosurgery and orthopedics.

da Vinci robotic assisted surgery is conducted with a surgeon sitting at a console operating several robotic arms that manipulate small tools; a tiny, lighted camera displays the surgical area in 3-D video. Incisions are made with scissors that are part of the robotic arms and tiny tools are then inserted into the incisions.

The specific problem that prompted the urgent medical notification is with da Vinci’s EndoWrist Monopolar Curved Scissors, which may develop so-called "micro cracks," said Intuitive Surgical in a statement. The cracks, which may not be detectable to the human eye, may release electrosurgical energy into patients bodies during surgeries, which could cause "thermal injury" to the body’s tissues. While Intuitive Surgical has stated that no injuries have been associated with the micro crack issue, six warnings have been issued for the da Vinci system’s scissors.

Personal injury lawsuits have alleged that the da Vinci robotic system has caused patients to suffer from a variety of adverse events including, serious internal injuries, many the result of burns, tears, and other complications. In some cases, patients have died or suffer from chronic pain, even disability. da Vinci lawsuits fault aggressive Intuitive marketing positioned to induce hospitals to buy the costly system. Lawsuits also allege that a collaboration of design flaws and poor physician training on the da Vinci caused serious injuries. At last count, about 70 deaths have been linked to the systems since 2009.

One lawsuit involves allegations that a patient’s death was accelerated because of prostate surgery conducted with the da Vinci system. Recent physician testimony indicated that the stress of the long surgery and the complications the patient suffered from that surgery brought about the man’s death, Bloomberg News reported. John S. MacGregor, a cardiologist and professor of medicine at University of California, San Francisco, told the jury that the man might have lived five more years, and with a better quality of life, had he not been harmed in the botched robotic surgery in 2008.

This week, Intuitive spokeswoman, Kate Lederer, testified that the company’s training is sufficient and complies with data submitted to the U.S. Food and Drug Administration (FDA) in 2000 when federal approval was sought for the da Vinci robotic system, wrote Bloomberg News.

The man’s widow alleges that da Vinci training was simplified to better enable Intuitive to sell more of the systems, which she claims led to errors during her husband’s prostate surgery. He died of heart disease at age 71 in 2012. Intuitive disagrees with the allegations, according to Bloomberg News, arguing that the surgeon in this case, urologist Scott Bildsten, performed 100 successful prostatectomies via traditional surgery. For his part, Bildsten testified that Intuitive deemed him sufficiently ready to operate on the da Vinci after receiving just one day of Intuitive training and two supervised surgeries. Bildsten never operated unassisted on a patient using the da Vinci prior to this surgery, according to a Bloomberg News report. He says he now realizes he should have received additional training before performing the unassisted robotic surgery.

The heavily marketed da Vinci was used in about 400,000 surgeries in just 2012 alone.

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