The robotic technology, called the da Vinci system, that assists in surgery has been on the market for more than a decade. More than one million procedures have been performed using this robotic device and between 2000 and 2012, thousands of mishaps have been reported to the FDA, as required. In most cases, the patient was not harmed, but among the reports, there were 174 injuries and 71 deaths related da Vinci surgery. Although many mishaps were reported, there were a handful of botched operations that were not reported to the FDA. Erin Izumi, who underwent robotically assisted surgery to treat endometriosis in March 2009, was one case of these unreported incidents. Ten days after her surgery, she was rushed to the ER, where doctors discovered that her colon and rectum had been torn during the operation. Even though hospitals are required to notify the FDA of these incidents within 30 days of the learning about it, there was no report in Izumi’s case. Nevertheless, robotic surgery has grown drastically in the past few years. About 1,400 da Vinci systems have been purchased by hospitals. The FDA stated that they have issued warning letters in the past when facilities have failed to report mishaps, and has said that they plan on taking further regulatory actions like injunctions or imposing civil financial penalties. A 2010 survey found that 56.8% of surgeons surveyed anonymously said they had experienced irrecoverable operative malfunctions while using the da Vinci system. If you or a loved one has suffered serious injuries as a result of a medical device, contact us immediately. Read more on this article.
Written by Andrew Finkelstein | Last Updated: June 17, 2021