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Surgical Robot is Under FDA Investigation

Update Date: Apr 10, 2013 12:35 PM EDT

Surgical operating robot da Vinci, used in 400,000 surgeries nationwide last year, is under close scrutiny.

Da Vinci is a million-dollar, multi-arm robot that assists in surgeries. Now doctors are concerned about a few freak accidents da Vinci has caused on the operating table, like not letting go of grasped tissue during surgery and even hitting one patient in the face as she lay on the operating table.

Procedures utilizing robotic surgery are often promoted on many U.S. hospital websites, in patient brochures and even on highway billboards. Da Vinci assists in operations such as removing prostates, gallbladders and wombs, repairing heart valves, shrinking stomachs and transplanting organs.

While the use of the surgical robot has increased worldwide, it is most common in the United States.

 "We are at the tip of the iceberg. What we thought was impossible 10 years ago is now commonplace," said Dr. Michael Stifelman, robotic surgery chief at New York University's Langone Medical Center.

Surgeons control the robot while sitting at a computer screen instead of standing over the patient. These operations sometimes have less bleeding than conventional laparoscopic surgeries and operations requiring large incisions, often permitting patients to be sent home sooner. Another benefit to da Vinci is its hands don't shake.

Earlier this year the Food and Drug Administration began a survey of surgeons using the robotic system and have found increased reported problems during surgeries. Reports also include at least five deaths.

FDA spokeswoman Synim Rivers said she couldn't quantify the increase and that it may simply reflect more awareness among doctors and hospitals about the need to report problems. Doctors aren't required to report such things; device makers and hospitals are, according to Time.

Wider use of the surgical robot may also be attributing to an increase in reported problems. Last year there were 367,000 robot surgeries compared to on 114,000 in 2008, according to da Vinci's manufacturer, Intuitive Surgical Inc. in Sunnyvale, Calif.

Da Vinci is Intuitive Surgical Inc.'s only product, as well as the only robotic system cleared for soft-tissue surgery by the FDA.

When a search for the company's name in an FDA database was conducted, 500 reports related to da Vinci were found since Jan. 1, 2012. The majority of the reports came directly from Intuitive Surgical, many of which happened several years ago and some of which were duplicates. There is no proof that any of the problems were caused by the robots. According to Time, reports include:

- A woman who died during a 2012 hysterectomy when the surgeon-controlled robot accidentally nicked a blood vessel.

- A Chicago man who died in 2007 after spleen surgery.

- A New York man whose colon was allegedly perforated during prostate surgery. Da Vinci's maker filed that report after seeing a newspaper article about it and said the doctor's office declined to provide additional information.

Complications can occur with any surgery, which is why is it difficult for the FDA to clarify whether or not robotic operations are increasing complications. Intuitive Surgical attributes the rise in reports to a change in the way problems have been reported since last year.

Da Vinci "has an excellent safety record with over 1.5 million surgeries performed globally, and total adverse event rates have remained low and in line with historical trends," said Angela Wonson, spokeswoman at Intuitive Surgical.

Research suggests problems linked with robotic surgery are underreported and even include cases with "catastrophic complications," said Dr. Martin Makary, a Johns Hopkins surgeon who co-authored the paper.

"The rapid adoption of robotic surgery ... has been done by and large without the proper evaluation," Makary said.

The surgical robot has been on the market since 2000, operating with three or four arms controlled by a computer system. It uses a tiny video camera attached to a long arm on the robot to see inside the patient's body while the other arms are equipped with tiny surgical instruments. Similar to conventional laparoscopy surgeries, robotic operations involve small incisions; they are merely controlled by the surgeon's hands from the computer.

Nearly 1 out of 4 U.S. hospitals is equipped with a da Vinci system costing approximately $1.45 million, with a approximately an additional $100,000 in fees for service agreements.

Approximately 85 percent of prostate operations in the U.S. are done with the robot. Da Vinci also is often used for hysterectomies, Wonson said.

Makary attributes the skyrocketing increase in robotic surgery, to aggressive advertising by the manufacturer and hospitals seeking more patients; he says there's no justification for it.

A study conducted by Makary in 2011 found 4 in 10 U.S. hospitals promoted robotic surgery on their websites, often using wording provided by the manufacturer. Some of the claims exaggerated the benefits or had misleading, unproven claims, according to the study.

It makes sense for hospitals to promote robotic surgery and other new technology to, but that it doesn't mean that it's the right option for all patients said Stifelman, of Langone Medical Center.

"It's going to be the responsibility of the surgeon ... to make sure the patient knows there are lots of options," and to discuss the risks and benefits, he said.

His hospital expects to do more than 1,200 robotic surgeries this year, versus just 175 in 2008.

Procedures in hard to reach places may benefit from robotic surgery, Makary said. Those procedures include head and neck cancer surgery and rectal surgery.

Dr. Subhashini Ayloo, a surgeon at the University of Illinois Hospital & Health Sciences System in Chicago finds da Vinci to be useful in surgeries with obese patients requiring kidney transplants. Some hospitals won't do transplants on obese patients with kidney failure because it can be risky.

A previous lawsuit in a case that turned fatal cited inadequate training with the robot. The family of Juan Fernandez, the Chicago man who died in 2007, was awarded $7.5 million for a malpractice case after a robotic spleen surgery. The lawsuit claimed Fernandez suffered a fatal infection after the surgeon punctured part of his intestines.

While the surgeons argued that Fernandez had a health condition that caused the intestinal damage, it was the first robot operation for one of the doctors. Using the robotic operation system was overkill for an ordinarily straightforward surgery, said Fernandez's attorney, Ted McNabola.

Physician -educators and other trainers at Intuitive Surgical teach surgeons how to use da Vinci, according to Geoff Curtis, company spokesman. However, they are not trained how to use the robot for specific procedures, he said it is up to hospitals and surgeons to decide if and when they are ready to use the robot. 

A 2010 essay in the New England Medical Journal published by a doctor suggests surgeons perform 150 procedures before the are adept to the surgical robot, but there is no expert concensus. 

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