Lapses Found in Adverse Event Reporting With Da Vinci Surgical Robot

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The U.S. Food & Drug Administration (FDA) requires medical device manufacturers and hospitals to report every device-related injury and death within one month of learning about the incident. However, information has recently surfaced about extensive lapses in reporting problems with the da Vinci Surgical Robot, a controversial device designed to facilitate complex surgery using a minimally invasive approach. Adverse events associated with the da Vinci Robot include injuries to internal organs, burns, and death.

In March 2009, Tacoma, WA. resident Erin Izumi underwent an 11 hour endometriosis surgery with the da Vinci Robot at St. Joseph Medical Center. Ten days later, Izumi was rushed to an emergency room, where it was discovered that her colon and rectum had been punctured during the operation. She was hospitalized for the next five weeks, and forced to undergo a number of surgeries to repair the damage.

It was later discovered that no record of Izumi’s case had been reported to the FDA in 2009. St. Joseph officials declined to comment, and a spokeswoman for Intuitive Surgical, the company that makes the da Vinci Robot, stated that it only became aware of the incident when Ms. Izumi filed a lawsuit. It disputed Izumi’s complaint and settled out of court in May 2012.

The FDA approved the da Vinci Surgical System in July 2000, making it the first robotic system to be used in U.S. operating rooms. The device allows the surgeon to get closer to the surgical site than conventional methods allow, and work at a smaller scale than would normally be possible. The da Vinci Robot consists of a viewing and control panel, and 3 or 4 surgical arms (depending on the model). When it first hit the market, the robot was used exclusively in gynecological procedures, but has since been increasingly used in prostate and gallbladder removals, heart surgery, hysterectomies and prostatectomies.

Since being approved in 2000, the da Vinci Robot has been named in thousands of adverse event reports submitted to the FDA. In most cases, the patients suffered no serious complications, but according to a recent study published in The Journal for Healthcare Quality, among the reports were at least 174 injuries and 74 deaths.

In addition to the reported adverse events associated with the da Vinci Robot, researchers at Johns Hopkins uncovered numerous examples of botched operations that were not reported to the FDA. They concluded that da Vinci Robot complications were ‘vastly underreported.’

It is commonly accepted that reports to the FDA represent a small fraction – experts estimate around 10% – of surgical complications and adverse drug reactions. The problem is that little is known of the real disadvantages of medical equipment and the injuries and deaths they may cause, even as robotic surgery is widely marketed to consumers.

Recent studies have suggested that surgeons may require as many as 200 procedures before they become proficient with the da Vinci Surgical System, which means that during the lengthy learning period, many patients will experience undesirable outcomes that are inferior to what might have otherwise occurred with an experienced surgeon. Da Vinci Robot Lawsuits allege that physicians were not adequately trained on proper use of the device, which may increase the risk of complications and injuries to patients.

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