According to the FDA, problems involving the da Vinci Surgical System are increasing prompting new recommendations for surgeons and calling for more robot surgery training. The problems continue to involve serious injury such as burns, tears, bowl perforations and even death.
An independent investment analysis firm issued a report on October 3rd regarding the increased da Vinci complaints, warning investors about the impact these incidents may have on the stock price for Intuitive Surgical, manufacturer of the da Vinci robot. The report involved figures such as the 2,332 da Vinci complaints received in the first eight months of 2013 as compared with the 4,603 complaints received over the past twelve years from 2000 through 2012. Here is what is even more disconcerting: another study suggests that these problems are often unreported. Who knows that the real data would show?
According to the reports the FDA has gotten, the majority of the medical device reports received pertain to device malfunctions such as component breakage, mechanical problems, and image or display issues. But the FDA has also received reports of injury and death related to the device. A recent analysis of the da Vinci robot prepared by the chief of adult cardiac surgery at Rush University Medical Center looked at 4,798 robotic surgery adverse events. This included 85 deaths, 414 injuries, and 3,402 cases of robot malfunctions.
Used for a number of different procedures including urologic, laparoscopic, and gynecologic procedures, these (sort of) automated procedures are aggressively promoted as a superior alternative to traditional surgery because it is less-invasive and results in reduced recovery times. But, a recent study has raised additional questions about the need for robotic-assisted surgery in many of these cases.
Houston, We Have a Training Problem
The FDA is now calling for doctors and hospitals to make certain that proper training is completed and that all surgeons are appropriately credentialed. In the past, doctors have come forward to tell how their hospitals have pressured them to use the machine on patients, even before the doctor is ready for that step. Some estimate that it can take between 200 and 750 surgeries to comfortably use the device – which is great if you are patient #751, not so much if you are #199. With a price tag of about $2 million, before training and maintenance, one could understand why surgeons may be “encouraged” to use the device as often as possible, but with the reported problems increasing at such an alarming rate, it’s worth taking another look at whether or not the da Vinci Surgical System provides sufficient benefits over the traditional procedures.
One University of Michigan professor said that “We don’t let inadequately trained people fly airplanes and excuse it by saying that added training is available for pilots who request it.” That is the problem, right? We are not requiring doctors to get meaningful training that reflects the challenges of using this equipment. Yes, there are problems with the robot itself and the fact that Intuitive Systems is not discerning in what procedures really make sense for these robots. No doubt. But a big part of the problem is that doctors just do not have the knowledge and experience to use this technology properly.
If you believe that you or a loved one has been injured during robotic surgery, contact our medical malpractice and medical device lawyers toll-free at 1.800.553.8083, or online.
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