Da Vinci Robot Investigated by FDA

Intuitive Surgical, the maker of the daVinci surgical robot, has found itself in new hot water recently. In addition to the multitude of lawsuits and at least one recall of its surgical shears, the medical device company was recently investigated by the United States Food and Drug Administration (FDA).*

Intuitive Surgical claims that it has taken the FDA investigative report very seriously and has “implemented corrective actions.”** The FDA investigation comes in the wake of a 34% increase in the number of adverse incidents associated with the daVinci robotic system.** Some of those resulted in patient death.** The report, dated May 30, actually details an investigation that took place over a period of about two months, in April and May of 2013.**

The FDA report contained four categories of mistakes that medical device manufacturer had made.**All mistakes involved not informing the FDA of field actions taken by Intuitive Surgical.** For example, the maker of the daVinci sent a letter to its customers instructing them on how to properly use the daVinci instruments with tip covers.** Prior to that letter, patients were injured by damaged tip covers that allowed electricity to escape burning patient tissue.** On a related note, Intuitive Surgical had failed to notify the FDA that it had sent yet another letter to its customers warning of the danger of defective cannulas that could result in patient injury.** Furthermore, the manufacturer had failed to let the FDA know that the company had sent letters to its customers alerting them to the fact that the daVinci surgical robot and instruments were not cleared for performing thyroidectomies or transoral surgery on children.**

In its report, the FDA called its findings “observations” and not final Agency determination regarding Intuitive Surgical’s compliance.* Intuitive Surgical will now have an opportunity to implement corrective action and/or object to the FDA investigator’s observations.*

If you or someone you know has been injured by the daVinci surgical robot or one of its components, please contact Audet & Partners, LLP by calling us toll free at (800) 965-1461. Alternatively, please complete and submit our confidential inquiry form on the right side of this page.  Please act now, since the law may limit your right to recovery if you delay

* FDA Inspection Report, (FDA May 30, 2013), http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/UCM358468.pdf

** Robotic Surgery Firm Faulted in FDA Report, (Medscape June 27, 2013), http://www.medscape.com/viewarticle/807003