Intuitive Surgical Warning Cites Unreported Field Corrections

Intuitive Surgical, a Sunnyvale, Calif., maker of surgical robots, failed to inform the FDA of several field corrections, resulting in a warning letter. The FDA cites examples of the failures in its July 16 letter, including a 2011 correction involving letters to customers with advice on the proper use of the surgical system’s tip cover accessory.
Devices & Diagnostics Letter