Intuitive Surgical Inc., the provider of robots used in surgery, is being probed by U.S. regulators over the safety of its products.
The regulators have asked surgeons at key hospitals to list any complications they may have seen with Intuitive’s robots, which cost $1.5 million each and were used last year in almost 500,000 procedures. The doctors were also surveyed on which surgeries the robots might be most and least suited for, and asked to discuss their training, according to copies of the survey obtained by Bloomberg News.
The answers are central to the outlook for the company. The robots and related products generated most of the Sunnyvale, California-based company’s $2.2 billion in revenue in 2012, and boosted its market value 70 percent over three years to about $23 billion before the survey was revealed, according to data compiled by Bloomberg. The shares dropped 11 percent to $509.89 at the close in New York, their biggest single-day slide since November 2008.
What the U.S. Food and Drug Administration is trying to determine with the survey is whether adverse incident reports sent to the agency are “a true reflection of problems” with the robots, or the result of other factors, Synim Rivers, an agency spokeswoman, said in an e-mail. “It is difficult to know why the reports have increased.”
Adverse event reports are sent to the agency by patients, medical professionals, and companies. They “can contain incomplete, inaccurate, duplicative, and unverified information,” Rivers said.
Hospitals that received the survey are members of a medical product safety network overseen by the FDA.
The robots are “extremely safe,” said Myriam Curet, Intuitive’s chief medical adviser, in a telephone interview. “There is a lot of redundancy in the system to make it as safe as possible.” The percentage of deaths and injuries involving the company’s da Vinci robotic system, is "extraordinarily small,’’ she added, and “hasn’t grown” over time.
In robot surgery, the physician sits at a video-game style console several feet from the patient, peering into a high-definition display while using foot pedals and hand controls to maneuver mechanical arms equipped with surgical tools. A camera provides a three dimensional view of the work being done inside the patient.
Martin Makary, a surgeon at Johns Hopkins Hospital in Baltimore who has researched the marketing of the systems, said the FDA probe now belongs in the larger debate.
“Patients need to know the truth about robotic surgery,” Makary said in a telephone interview. “The Achilles-heel feature” of the robot is its lack of tactile feedback, which can spur “inadvertent injuries if added caution is not taken.”
While the number of adverse event reports to the FDA can be misleading, they’ve also served in the past as an early warning system on concerns about medical devices.
The reports reviewed by Bloomberg outline serious complications, including gynecological surgeries that make up about half of the procedures involving Intuitive’s robotic system. They include damage to ureters and bowels as well as instances when instruments broke off from the robot and fell into a patient. Reports also cited burns to various organs or vessels, most repaired during the surgery itself.
Many of the reports were filed by Intuitive Surgical and state that no robot malfunction was found or that the problem came from user error. Several originated from patients, who aren’t identified.
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