Federal Regulators Investigating the Da Vinci Robotic Surgery System


Questions about the use of robotic surgery over other minimally invasive procedures, and a rise in adverse event reports, prompted a safety probe of the da Vinci surgical robot manufactured by Intuitive Surgical by U.S. federal regulators.

The U.S. Food and Drug Administration is seeking information from surgeons at key hospitals regarding complications seen with the da Vinci and the surgeries robotic surgery devices are best and least suited for, said Bloomberg.com. Surgeons were also asked questions concerning their training on the da Vinci, according to survey copies Bloomberg News obtained.

The surveys were sent by an FDA-managed product safety network and seek to determine if the rise seen in incident reports are “a true reflection of problems” with the da Vinci or due to other issues, Synim Rivers, an FDA spokeswoman, wrote to Bloomberg News. “It is difficult to know why the reports have increased,” she said. According to Rivers, the reports are sent by patients, medical professionals, and firms and “can contain incomplete, inaccurate, duplicative and unverified information.” Reports detail serious complications; gynecological surgeries comprise about half the da Vinci surgeries and typically involve ureter and bowel damage, instances in which instruments broke away from the da Vinci and fell into patients bodies, and burns to vessels and organs, Bloomberg.com explained. Many incident reports were filed by Intuitive; the device maker asserts that the issues originated with user errors and that no robot malfunction occurred, said Bloomberg.com.

Some 1,370 hospitals nationwide have purchased one of the expensive robots—they cost $1.5-$2.2 million each—yet, some studies suggest that the da Vinci Surgical Systems might not offer any significant health or financial benefits. According to a recent The Wall Street Journal report, the da Vinci Surgical Robot System, which is manufactured by Intuitive Surgical Inc. of Sunnyvale, California, costs about 30 percent more than other minimally invasive surgery.

The da Vinci Surgical Robot System is the only such device of its kind that is used for general surgery and has been used in a broad and growing range of procedures such as prostate, gallbladder, cardiovascular, and gynecological surgery, to name just some. In robotic assisted surgery, a surgeon is seated at a console operating four robotic arms that manipulate small tools that are inserted into the patient via tiny incisions; the system also utilizes a small, lighted camera that displays the surgical area in 3-D video.

Some argue that robotic surgery creates less scarring, pain, and blood loss; decreased complications; shorter hospital stays; and quicker recovery, when compared to traditional open surgery in which a larger incision is made and the healing time is longer. Critics of the device say it is the minimal invasiveness of the procedures and not the robotics that offer the advantage. Consider, noted the Journal, laparoscopic surgery that involves surgeons manipulating specialty tools, utilizing video, and creating small incisions, at a significantly lower cost.

The robots are “extremely safe,” Myriam Curet, Intuitive’s chief medical adviser, told Bloomberg News in a telephone interview. “There is a lot of redundancy in the system to make it as safe as possible.” The number of fatalities and injuries related to the da Vinci, she said, “is extraordinarily small,” she added, and “hasn’t grown” over time.

Martin Makary, a surgeon at Johns Hopkins Hospital in Baltimore who researched the marketing of the da Vinci systems, told Bloomberg News, “Patients need to know the truth about robotic surgery…. The Achilles-heel feature” of the da Vinci is that it does not allow for so-called “tactile feedback,” which can lead to “inadvertent injuries if added caution is not taken.”

As we’ve written, four personal injury lawsuits alleged the da Vinci Surgical Robot allege severe internal injuries, including burns, tears, and other complications, some of which had resulted in death or chronic pain and disability. Among other things, da Vinci Surgical Robot lawsuits fault the aggressive marketing tactics used by Intuitive to convince hospitals to purchase the expensive surgical robot, and allege that a combination of design flaws inherent in the robot, coupled with poor physician training on the device, have resulted in serious injuries.

Last May, we wrote that another lawsuit had been filed by a victim of an allegedly botched surgery using the da Vinci Surgical Robot. In that case, an Alabama woman claimed that Intuitive Surgical suppressed complaints and concealed rates of complications associated with the robot from the public and federal health regulators. She seeks $270 million in damages. That complaint is among several lawsuits filed nationwide that allege that da Vinci Surgical Robot design flaws, coupled with a lack of adequate training on the part of surgeons who use the device, have caused serious injuries to patients, including tears and burns to blood vessels, the intestines, and the uterus, as well as vaginal cuff dehiscence, to name just a few.

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