Intuitive’s da Vinci Fails to Warn FDA of Problems
In a recent inspection of Intuitive Surgical, the makers of the da Vinci surgical robot, the FDA found that Intuitive broke protocol when it warned customers of problems with one of the surgical equipment pieces without alerting any regulators. According to the FDA, in October 2011, Intuitive sent customers a warning letter advising of corrections in using da Vinci surgical instruments with tip covers without advising the any government regulator of these complaints.
Click here to read the full CNBC article: FDA: Intuitive Surgical Failed to Report Warning
According to the FDA 483 letter, the FDA found that “specifically Intuitive Surgical undertook four field actions…without notifying the San Francisco District Recall Coordinator of these actions.” While Intuitive Surgical took the time and effort to alert their clients of potential problems with these instruments, Intuitive did not notify the FDA of any of these complaints, corrections, and procedural changes. Instead, Intuitive chose to notify only their customers.
Intuitive maintains that the corrective letter sent to clients “was a reiteration of existing FDA-cleared labeling that reminded users on proper use. “
One of the leading robot surgeries is the da Vinci robot machine-made by Intuitive Surgical Inc. It was first FDA approved in 2000 for adult and pediatric use in urologic surgical procedures, gynecologic surgical procedures, as well as other procedures. The robot costs in excess of one million dollars. Intuitive based in Sunnyvale, Ca, outside of San Francisco, is the only company whose surgery system is cleared for soft tissue procedures that include general surgery, prostrate operations, and gynecological surgery.
If you are a patient considering a da Vinci robot surgery, you may wish to ask your doctor about alternatives for your particular problem. If you or a loved one has been injured from a procedure involving the da Vinci robot, and wish more information about your legal rights, you can contact the lawyers at the Brandi Law Firm (1-800-481-1615 or email us).