Intuitive—da Vinci Si and Xi Surgical System Surgeon Side Consoles: Circuit Board May Fail, Potentially Rendering Surgeon Console Inoperable and/or Resulting in Error Message
March 15, 2017 | Risk Management News
In a February 24, 2017, Field Safety Notice Urgent Medical Device Recall letter, Intuitive states that one of the circuit boards on the above consoles may fail, leaving the console inoperable (i.e., may not power on) and/or resulting in a nonrecoverable message (System Error 90). Intuitive also states that in the worst case scenario, this problem will result in the console failing to power up or encountering a nonrecoverable fault, preventing use of the console. Intuitive further states that it has received no reports of injuries or deaths as a result of this problem.
Action Needed:Identify any affected consoles in your inventory. If you have affected consoles, verify that you have received the February 24, 2017, Field Safety Notice Urgent Medical Device Recall letter and Acknowledgment Form from Intuitive. An Intuitive representative will contact your facility to arrange to address this problem. Notify all relevant personnel at your facility of the information in the letter, and retain a copy of the letter and Acknowledgment Form with your records. Complete the Acknowledgment Form, and return it to Intuitive using the instructions on the form. Log into the da Vinci Online Community Field Action resource...