Da Vinci Surgical System Adverse Event Reports Prompt FDA Inquiry
The Food and Drug Administration is currently looking into whether or not a device meant to aid in a surgeon’s ability to safely conduct procedures instead poses a risk to patients. In doing, the agency hopes to establish whether or not user error or a problem with the device itself could be to blame for those reports that have already come in.
The da Vinci surgical system is the medical device in question. The $1.5 million device works by way of a high definition camera and group of surgical instruments at the ends of robotic arms, all of which are controlled by a medical professional. A new report finds surgeons from the Ventura County area stepping up to defend the system, saying that precise movements and lack of tremors are a few of the many benefits of the system.
One surgeon says that any errors would be on the person conducting the procedure via the da Vinci. Intuitive Surgical, the company behind the device, has related many reports to the FDA that claim the same.
Among the reported incidents are instances where the patient was burned during the procedure or parts of the device dropped into the patient. Although the FDA says that there has been a recent uptick in adverse events related to the product, a spokesperson for Intuitive Surgical denies this assertion.