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April 12, 2013

FDA launches investigation into da Vinci complaints

Daily Briefing

FDA is investigating a spike in reported problems involving da Vinci surgical robots, which were used in nearly 400,000 surgeries across the country last year.

The da Vinci system has been on the market since 2000 and allows surgeons to perform procedures using hand controls at a computer system several feet from the patient. The three- or four-armed robot can see inside a patient's body using a tiny video camera attached to one of the arms.

The da Vinci is used for operations that involve removing prostates, gallbladders, and wombs, repairing heart valves, shrinking stomachs, and transplanting organs. About 1,400 U.S. hospitals—nearly one in four—have at least one da Vinci system, and each of those systems costs $1.45 million, plus $100,000 or more annually for service agreements.

Seeming uptick in patient incidents

Recent reports of problems, including up to five potentially related deaths, have brought new scrutiny on the da Vinci system, the Associated Press's Lindsey Tanner reports.

Altogether, a search for da Vinci's manufacturer, Intuitive Surgical, in an FDA medical device database revealed 500 events since Jan. 1, 2012. Some of those events are several years old or are duplicates, while many did not involve patient harm and none contained proof that the robot caused the problem. However, reports filed this year included a woman who died when a robot accidently clipped a blood vessel and a man whose colon was perforated during prostate surgery. Many of the reports were filed by Intuitive Surgical.

It is uncertain whether the rise in reports received by FDA accurately reflects the number of da Vinci-related incidents, according to the AP. FDA spokesperson Synim Rivers says that the increase may reflect more awareness among doctors and hospitals. It also could be a symptom of wider use—Intuitive reports that 367,000 robot-assisted surgeries occurred last year, compared with 114,000 in 2008.

Meanwhile, Intuitive disputes the numbers, saying that the rise reflects a change in how the company reports incidents. The da Vinci system "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," says spokesperson Angela Wonson. "The FDA routinely asks medical device companies and hospitals for information, clarification or additional data as part of post market surveillance," she added in a statement.

Reports invites fresh look at robotic surgery

The incident has reignited a long-running debate among health care providers over whether robotic surgery offers advantages, or whether its benefits are exaggerated.

Surgeons who use a robotic system say that it leads to shorter hospital stays and is safer than surgery using large incisions. However, critics argue that robotic surgeries cost more and are not necessarily better. A 2010 NEJM essay also noted that there is no consensus on how much training surgeons need to use the robot (Tanner, AP/USA Today, 4/9; Xavier, Silicon Valley Business Journal, 4/10).

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