Robot surgeon facing lawsuits

The leading robotic surgical system is manufactured by the American company Intuitive Surgical and named after the anatomical pioneer and inventor of the first robot, Leonardo da Vinci. Designed to facilitate complex surgery using a minimally invasive approach, its 4 robotic arms are controlled by a surgeon from a console with a stereoscopic 3D view of the operation, magnified up to 10 times..

First introduced in the U.S. in 2000, da Vinci robots now operate in several thousand hospitals worldwide, with an estimated 200,000 surgeries conducted in 2012 alone. Most commonly used for hysterectomies and prostate removals the robot surgeon has been used in almost 1.5 million operations in the past decade. As of January 2013, more than 2,000 units have been sold worldwide. The current version of the robot costs on average US$2.5 million, in addition to several hundred thousand dollars of annual maintenance fees.

The benefits of robot surgery are great, less blood loss, smaller scars and a speedier recovery time, however no system is foolproof and in the case of surgical complications, who is responsible the robot or its operator?

Reports of such adverse events have risen recently, prompting a January survey of surgeons using the system by the US Food and Drug Administration (FDA). Bloomberg Businessweek reported earlier this month that 10 product liability lawsuits have been filed against da Vinci’s makers in the past 14 months.

The lawsuits, which the firm is defending, allege that the da Vinci has caused liver and spleen punctures during heart surgery, rectal damage during a prostate operation, and a vaginal hernia after a hysterectomy. There are also a number of cases of unintended burns from the robot’s cauterising tools. The FDA’s inquiry, says spokeswoman Synim Rivers, aims to “determine if the rise in reports is a true reflection of problems, or simply an increase due to other factors”.

Intuitive Surgical spokeswoman Lauren Burch denies there is cause for concern “Rates of adverse events or death for da Vinci surgery have not increased over the past several years. The clinical evidence shows that da Vinci is safer than open surgical alternatives in many common procedures,”

One regular da Vinci user, Ben Challacombe, a consultant urologist at Guy’s and St Thomas’ NHS Foundation Trust in London says the legal issues Intuitive Surgical faces are far more likely to be down to incorrect use by surgeons rather than robot faults. “The console has brilliant, unsurpassed 3D vision, unlike laparoscopic systems with 2D screens,” says. “It also has fantastic control instruments that filter out hand tremors, whereas long laparoscopic tools only enhance tremor.”

Studies seem to agree showing there is a learning curve with new surgical technologies, during which there is an increased complication rate. And with some surgeons only receiving two days’ training on da Vinci the technology itself may well not be to blame.

Sourced from The New Scientist, Wikipedia

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