Claims Mount for Da Vinci Robot Use
- Intestinal burns or tears
- Puncturing of blood vessels or ureters
- Bowel injuries
- Vaginal cuff dehiscence
More about Medical Device
The da Vinci robot is a complex, remote-controlled device that is promoted as an alternative to traditional surgical procedures. The medical device was approved by the U.S. Food & Drug Administration (FDA) in 2000 for use in urologic, laparoscopic, gynecologic and non-cardiovascular thoracoscopic surgical procedures.
The da Vinci robot has four arms—three of which, are used to accommodate surgical instruments, and the fourth used to offer an endoscopic camera. The remote-controlled da vinci robot was created to provide a surgeon more range of motion than the human hand, while giving patients less invasive surgery with a smaller incision and reduced recovery time.
Company’s website states that: “The system cannot be programmed and it cannot make decisions on its own. The da Vinci surgery requires that every surgical maneuver be performed with direct input from your surgeon.” Which illustrates the importance of surgeon training.
Promise to Hospitals
A driving force for hospitals to purchase the expensive robots, ranging from $1 million to $2.25 million, was to remain competitive, which was especially attractive to smaller hospitals. On top of initial investment, device’s annual maintenance expense could be $140,000 per year and replacement parts, after each procedure, $1500-$2000.
With its huge costs, surgeons were encouraged to use the devices as much as possible. Several lawsuits alleged that surgeons were not receiving enough training on the device—in a few instances—only a two-day course before they used the sophisticated da Vinci robot unassisted.
Case in Point
A Washington complaint says the doctor relied on the da Vinci system to perform the surgery, but had never used it on a patient without being supervised, according to court filings. Victim’s family who brought the Intuitive Surgical lawsuit accused officials of failing to properly train doctors about the da Vinci robot then recommending they perform unsupervised surgeries too quickly. The judge, in this particular case, said state product-liability laws do say medical-device makers have a duty to adequately train doctors to safely use their systems.
Pushed to Perform Surgeries
One of the main allegations in recent davinci lawsuits is that Intuitive Surgical provided insufficient training for the medical devices in its push to speed revenue growth.
By 2010, more than 850 hospitals in the U.S. had purchased the da Vinci robotic surgery device, according to a report by the Wall Street Journal. The editorial points out smaller hospitals were particularly targeted (at least 15% of the hospitals owning the da Vinci robot had 200 or fewer beds). This further increased the risk of problems because smaller hospitals usually don’t have enough procedures to allow doctors to become proficient in using a complex medical device.
In tandem, patients were also not being warned that while a surgeon is learning the new techniques required by the da Vinci surgery they may be exposed to an increased risk of serious and potentially fatal complications and problems.
Safety Now Questioned
A number of surgeons and health experts are expressing concern over the Da Vinci Surgical System. Both the Kaiser Foundation and the American College of Obstetricians and Gynecologists have individually raised concerns, and a report in the January 2012 issue of the Journal of Clinical Oncology found that the da Vinci robot appeared no more effective at treating women with endometrial cancer than traditional surgery, and using the da Vinci robot cost $1,300 more.
Others have also claimed that Intuitive Surgical has failed to perform or sponsor ongoing testing to determine whether da Vinci robotic surgery is any safer or more effective than other surgical and laparoscopic methods.
Another complaint points to potential device design flaws and its reliance on monopolar energy, which can increase the risk of surgical burns. While other lawsuits, claim burns were caused from device’s failure in providing insulating barriers.
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