A warning at the end of May 2016 was issued by Intuitive Surgical concerning a risk that small particles could be introduced inside the heart during intra-cardiac procedures using its da Vinci Xi device. The da Vinci Xi received U.S. Food and Drug Administration (FDA) clearance in April 2014.
The Sunnyvale, California-based Intuitive said it has not received any reports of injuries connected to the high-density polyethylene particles it found during quality inspections of its 5 mm-8mm universal seal or the 12 mm and stapler universal seal used with the da Vinci Xi. Intuitive Surgical said the particulate was found in the insufflation stopcocks used with the seals, reports Mass Device.com.
The warning was initiated by Intuitive Surgical to alert those affected due to the risk of foreign body embolism should particulates remain undetected and unintentionally left inside the heart. “If the potential particulate is undetected and unintentionally left behind, health risk is minimal due to the bio-inert properties of the high density polyethylene (HDPE) particulate, its small size and the benign particulate geometry.”
A complaint was recently filed in Georgia’s Northern District Court by a group of heart surgery patients claiming the da Vinci surgical robot caused metallic debris to end up in their brains after mitral valve surgery. The plaintiffs claim that Intuitive Surgical manufactured and marketed the da Vinci device despite knowing the potential risks due to defects that could cause metallic microemboli in patients undergoing these types of surgeries, according to Mass Device.com.
The da Vinci System has brought minimally invasive surgery to more than 3 million patients worldwide, and is used for cardiac surgery, among other kinds of operations, according to their website. “The da Vinci system is powered by robotic technology that allows the surgeon’s hand movements to be translated into smaller, precise movements of tiny instruments inside the patient’s body. The surgeon is always in control of the da Vinci System,” according to the da Vinci Surgery website.