Complaints Against Da Vinci Surgical System. The da Vinci Surgical System offers a minimally invasive alternative to both open surgery and laparoscopy.
“It requires only a few tiny incisions and offers greater vision, precision and control for the surgeon. Patients often can recover soon, move on to additional treatments if needed and get back to daily life more quickly,” according to a statement by Cancer Treatment Centers of America.
However, a group of heart surgery patients are filing a complaint in Georgia’s Northern District Court, claiming its da Vinci surgical robot cause metallic debris to end up in their brains after mitral valve surgery, reports Mass Device.com.
According to court documents, plaintiffs in the case claim that Intuitive Surgical designed, manufactured, and marketed the da Vince device with knowledge of defects that may cause metallic micro emboli in patients having mitral valve surgery.
Surgical Issued Warning About the Risk
The plaintiffs are looking to turn the case into a class action suit representing all patients undergoing similar complaints. Their allegations include physical, neurological and mental injury, along with emotional distress and extra medical expenses. Punitive damages are being sought in the case along with damages in excess of $5 million, Mass Device.com reports.
Intuitive Surgical issued a warning in May that there exists a risk of small particulates being introduced inside the heart during intra-cardiac procedures using its da Vinci Xi device. “The particulate has the potential to be introduced into the cannula lumen when insufflation is connected.
We are initiating this warning for use in intra-cardiac procedures due to risk of foreign body embolism should particulates remain undetected and unintentionally left inside the heart,” Intuitive Surgical said.
The Sunnyvale, California-based Intuitive revealed, it “has not received any reports of injuries related to the high-density polyethylene particles during quality inspections of its 5mm-8mm universal seal or the 12mm and stapler universal seal used with the da Vinci Xi,” reports Mass Device.com.