FDAnews Device Daily Bulletin

Intuitive Surgical Releases Safety Notice on Use of da Vinci Instruments

April 19, 2016

Intuitive Surgical has issued a safety notice to customers regarding the use of da Vinci EndoWrist instruments with a cardiac cryoablation probe, due to the potential risk of producing metallic microemboli during intra-cardiac surgery.

Customers are advised against using any da Vinci instruments — other than the Cardiac Probe Grasper — to manipulate a cardiac cryoablation probe, following reports that it may lead to an increase in the amount of microscopic metallic particulate, the notice states.

The company received five reports of MRIs from da Vinci mitral valve repair patients which showed metallic microemboli; however, it remains unclear that the presence of particulate is linked to da Vinci systems. — Anisa Jibrell