July 15, 2013 — The U.S. Food and Drug Administration (FDA) and Intuitive Surgical Inc. have announced a Class II da Vinci Surgical Robot recall. The problem is that 30 of the devices were not tested properly before they were sold, because “one of the testing devices was found to be working incorrectly.”
Intuitive Surgical issued an Urgent Device Correction Notice on June 27, 2013. The warning instructed customers about the problem.
The recall affects components of the Endoscopic Instrument Control System. The endoscope is a surgical scope that uses a tiny camera attached to a long, thin tube. The surgeon makes a narrow incision and inserts the scope into the patient’s body to visualize organs or tissues. The scope may also have surgical instruments that can perform biopsies or surgeries inside the body.
Da Vinci Surgical System recall affects the following devices:
- Da Vinci Si Vision System Cart
- Da Vinci Si Surgeon Side Cart
- Da Vinci Instrument Control Box
- Da Vinci Dual Camera Controller