Intuitive Surgical Robotic Device Settles Case After Botched Procedure

A woman who alleged she was injured by Intuitive Surgical Inc.’s surgical robotic device has agreed to settle her lawsuit.

Jennifer Silvestrini underwent a robotic transaxillary total thyroidectomy at Tulane University Hospital and Clinic (TUHC), for which an Intuitive da Vinci Surgical System was used. The device malfunctioned but neither her surgeon nor the hospital staff was able to fix the problem, the lawsuit states. After efforts to reach an Intuitive technician allegedly failed, the surgeon converted the procedure to a “traditional” one, making a long surgical cut in the patient’s neck.

The patient originally filed suit in the District Court for the Parish of Orleans, accusing Intuitive for failing to adequately maintain the device, failing to train TUHC personnel on the use of and/or troubleshooting the device and failing to have a technician readily available who could troubleshoot and restart the device, as contracted for with TUHC.

Intuitive removed the case to federal court in October 2011 and the parties eventually began settlement discussions.

The allegations made in her case, including failure of Intuitive to train hospital personnel on the use and/or troubleshooting of the da Vinci System, are consistent with problems encountered by so many patients who experienced injuries associated with this surgical robot.

There are currently no strict guidelines or requirements associated with a doctor’s operation of the robot on a live patient. This is left up to the individual doctors and/or hospitals’ discretion. Anonymous personnel have stated that their training included only two days of operating on a pig and human cadavers.

In response to a recent lawsuit, Intuitive argued that because “credentialing and privileging” for performing surgery at a hospital is the sole responsibility of the hospital, “the case should be dismissed.”

Lawsuits continue to be filed in connection with injuries sustained by patients at the hands of inadequately trained physicians using the robot.

The American Association of Gynecologic Laparoscopists suggests at least ten (10) supervised surgeries before allowing doctors to use the robot without supervision.

A recent Bloomberg report suggests that Intuitive Surgical Inc., the manufacturer of the da Vinci System, has provided less than adequate training to doctors and hospitals that have deployed this robotic technology. It is alleged that this lack of training may have directly contributed to injuries suffered by many individuals who have undergone procedures using the da Vinci robot.

Dr. Jim Hu, director of Urologic Robotic and Minimally Invasive Surgery at the David Geffen School of Medicine at the University of California Los Angeles indicates that, “The robot surgery requires a long learning curve to become good at it,” and specifically referring to prostate cancer surgery, Hu says that proficiency can take up to 200 plus operations to achieve. Dr. Hu assisted on 400 robot surgeries prior to performing them on his own. “None of us would go and get surgery if we knew the guy had done it just a couple of times before,” he said.

According to a recent study conducted by the Mayo Clinic, published in the Obstetrics and Gynecology medical journal, surgical proficiency, “occurs after performing approximately 91 procedures.”

During two routine hysterectomies at Wentworth Douglass, a physician accidentally cut the ureters of the patients. Subsequently, the physician performing the surgery and the supervising physician were both required to undergo remedial training. Too bad these doctors weren’t required to undergo proper training prior to performing surgery on patients.

Would you worry that your surgeon has not successfully received training in a procedure he is willing to perform on you? Most of us would never think this is possible. It is unacceptable that any physician would risk a patient’s life performing surgery that they have only done twice before on a pig. Feel free to comment on this blog post.

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