New Study Finds that Complications From Da Vinci® Robotic Surgery Are Vastly Underreported
The Da Vinci® Surgical Robot is manufactured and marketed by Intuitive Surgical, Inc. It is used in a number of surgical procedures across the country, including hysterectomies, gastric bypasses, prostate removals, gallbladder removals, and thyroid cancer surgeries. In July, the FDA issued a Class 2 Recall on approximately 30 Da Vinci® Surgical Robots after one of the affected devices was discovered to be malfunctioning.
A recent study published in the Journal for Healthcare Quality suggests there may be more complications – including burns, tears, and other internal injuries – associated with the surgical device that are not being reported to the FDA. According to researchers from Johns Hopkins, this underreporting of complications may be misleading the public as to the device’s safety. Since 2000, there have been about one million robotic surgeries performed with the Da Vinci® device. However, since that time there have only been 245 reported complications, including 71 deaths and 174 nonfatal injuries. The researchers were suspicious of these low numbers. Dr. Martin Makary, the lead researcher, explained: “The number reported is very low for any complex technology used over a million times. Doctors and patients can’t properly evaluate safety when we have a haphazard system of collecting data that is not independent and not transparent.”
As a result, the researchers set out to investigate reported and unreported incidents of complications associated with the device. The researchers discovered a number of incidents where problems following robotic surgery were not reported to the FDA until long after they had occurred and had already been publicized by the media. In particular, eight cases were identified where FDA reports were improperly filed. The researchers also identified five incidents that were never reported to the FDA and two incidents that were reported only after the media covered a story on the incident. Researchers believe there are other incidents of complications associated with the Da Vinci® device that have not been reported, since a previous study found that nearly 57% of surgeons anonymously reported operative malfunctions while using the device.
In conjunction with these safety concerns, Intuitive Surgical faces an ever-increasing number of lawsuits brought by patients who have experienced burns, tears, and other serious – and even deadly – injuries. These lawsuits outline the aggressive tactics used by Intuitive Surgical to market the device and raise questions about the quality of training provided to surgeons.
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