The complaint was filed this week in Georgia’s Northern District Court.
Plaintiffs in the case, Gabrial Nassar Cure and Dr. Alan Kozarsky, claim that Intuitive Surgical and up to 10 John Does designed, manufactured and marketed the da Vinci device despite knowing of defects that could cause metallic microemboli in patients as a result of such surgeries, according to court documents.
Both plaintiffs underwent mitral valve surgery with the da Vinci device last year, and claim to have found evidence of metallic fragments in their brains post-surgery, attributing the microemboli to the da Vinci device.
Plaintiffs in the case claim the metallic microemboli have cause physical, neurological and mental injury, as well as emotional distress and extra medical expenses, and are looking to turn the case into a class action suit representing all patients in similar circumstances.
Damages in excess of $5 million are being sought in the case, as well as punitive damages.
In May, Intuitive Surgical warned of the risk that small particulates could be introduced inside the heart during intra-cardiac procedures using its da Vinci Xi device.
Sunnyvale, Calif.-based Intuitive said it hasn’t received any reports of injuries related to the high-density polyethylene particles it turned up during quality inspections of its 5mm-8mm universal seal or the 12mm & stapler universal seal used with the da Vinci Xi. Intuitive said the particulate was found in the insufflation stopcocks used with the seals.