The Da Vinci Robotic System entered the medical world with a certain amount of hype and expectation. Both doctors and patients know that the future of medicine lies with steadily improving technology. The limitations of the human body will inevitably be augmented by precise robotic instruments. The Da Vinci Robot was a step in that direction. Unfortunately, despite it’s early impressions, more and more cases of injury are being reported as a result of the machine. Worse yet, it is being suggested that surgeons in a rush to be on the ‘leading edge’ have been undertrained and underprepared for work with the system. On the corporate end, developer Intuitive is being accused of withholding warnings and injury assessments from the FDA.
Is Da Vinci Surgery Dangerous?
So far there have been numerous reports of injuries in correlation with Da Vinci usage…however injury reports are par for the course when dealing with surgeries of any kind. The real issue is the preventable nature of the injuries which are a result of either lack of product testing or lack of user training. The specifics on where blame lies is at the heart of current Da Vinci cases. Manufacturer Intuitive is suggesting that there have been over 1.5 million Da Vinci surgeries performed and that the corresponding amount of injuries is low. The injuries, they claim, are a result of mishandling the product moreso than the product itself. Coversely, surgeons are claiming that they have not been made suitably aware of the dangers of the device or ways in which it can malfunction. Ultimately the injured patience just want some financial restitution, but their legal representatives are aiming more of their efforts toward the manufacturer than the actual surgeons.
The Problem With FDA Notifications
One of the more serious accusations raised against Intuitive is that they were intentionally withholding information from the FDA. As reported by Injury Lawyer News: “The recent letter sent from the FDA was dated July 16, 2013. In it, the agency warned Intuitive Surgical of numerous instances where the company failed to notify the FDA of correspondence sent to clients and medical providers. These actions violate federal regulations that require medical device manufacturers to notify the FDA of such correspondence within 10 days. The letter comes after an FDA inspection of one of the company’s production facilities, which took place between April 1 and May 30, 2013. The FDA letter cited numerous instances where the company failed to properly notify the agency of such communications. The first involved correspondence regarding damaged tip covers on the device that led to some patient injuries. The second involved da Vinci robotic surgery problems during thyroid surgeries, which the device had not received clearance for. The third provided information about the proper inspecting and flushing of cannulas. All of these correspondences took place in October, 2011.”
The Next Step For Injured Patients
Sales and revenue for the Da Vinci machine have slowed, however there are already hundreds of units out across the country. That means the reports of injuries are likely to continue and you may find yourself with the option of receiving Da Vinci treatment. If you or a loved one experienced injury as a result of Da Vinci surgery, it is important to record as much information as possible about the circumstances of your procedure. Determining wether or not your surgery was unaware of the risks, or if he/she was negligent in training, can effect the course of the case. If you need more answers or information regarding Da Vinci surgery, reach out to us at 1-800-603-6833.