da Vinci Robot Cited by FDA for Possible Inadequate Testing
Audet and Partners, LLP, reports that the United States Food and Drug Administration (“FDA”) has issued a Class 2 recall of 30 da Vinci systems.* The recall, issued to da Vinci’s manufacturer, Intuitive Surgical on July 11, 2013, states that these systems may have been inadequately tested prior to deployment in hospitals and medical practices throughout the United States.*
A spokeswoman for Intuitive Surgical stated in response to the recall notice that “one piece of equipment wasn’t recording results properly.”*
A Class 2 recall is defined by the FDA as “a situation in which the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”**
In response to the recall, Intuitive Surgical issued an Urgent Device correction notice to its affected customers.* This was not the first such notification issued by Intuitive related to the da Vinci robotic surgical system this year. On May 8, 2013, the company issued an Urgent Medical Device Notification regarding the issue of unintended electrical discharge that could result from micro-cracks in since-replaced scissors that are part of the da Vinci surgical system.***
Bill Audet, Managing Partner at Audet and Partners, LLP, notes mounting concerns with the da Vinci robotic surgical system. “This most recent recall addressing possible lax testing further supports a theory that the company may have rushed this product to market to secure a competitive stronghold in the nascent robotic surgery niche. We continue to speak with individuals on a regular basis who have allegedly suffered injuries as a result of da Vinci surgery of a nature that simply would not have resulted from traditional laparoscopic surgery. We are encouraged, however, that the FDA is more closely examining the adequacy of testing of this potentially dangerous surgical system.”
If you or someone you know has suffered an injury that may be related to the da Vinci robot or any of its components, please contact Audet & Partners, LLP by calling us toll free at (800) 965-1461, or visit our informational website at http://www.davinci-surgical-robot-lawsuit.com.