The FDA has said Intuitive Surgical Inc., the company that makes the da Vinci surgical robot system, told its customers that 30 of the devices related to the robot may not have been properly tested. Improper testing is a common cause of product liability claims and certain medical malpractice claims. The FDA says there is now a class 2 recall of:
- da Vinci Si Vision System cart
- Instrument control box
- Si surgeon side cart
- Dual camera controller
Bloomberg News reports that Intuitive Surgical Inc. said that during the testing phase of these devices, there was an instrument that was not recording the results of the tests correctly. The company went on to say that the devices have been retested in the field and that they all met safety standards.
The da Vinci robotic surgical system has been in hot water lately. At the beginning of this year, the FDA began surveying surgeons using the system, because the agency has received a considerable number of adverse event reports. In an adverse event report, patients and doctors can report injuries and deaths that have occurred during procedures using certain devices. Although these reports do not prove the da Vinci caused the injury or death, it raises the possibility that it did.
If you or a loved one has been injured during a procedure using the da Vinci robotic surgical system, please contact the Law Offices of Michael Barszcz, M.D., J.D., to schedule a free consultation with our experienced Orlando defective medical device and medical malpractice lawyer.