Intuitive Surgical, Inc. recalls 30 deg, 8mm Endoscope, IS4000: Model numbers: 470027-34, 470027-40, 470027-41. General and Plastic Surgery: The da Vinc…

Recall date

November 23, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0653-2016

FDA classification

Class II

Brand / firm

Intuitive Surgical, Inc.

Sold / distributed

Worldwide Distribution - US (nationwide) and Internationally to Australia, Austria, Belgium, Cyprus, Czech Republic, Denmark, France, Germany, Hong Kong, India, Israel, Italy, Japan, Monaco, Netherlands, Norway, Puerto Rico, Qatar, Romania, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switz…

Why it was recalled

This correction to the da Vinci Xi I&A User Manual communicates proper use of the da Vinci Xi 8 mm Endoscopes in combination with the da Vinci 8 mm and 12 mm cannulae, cannula reducers, and monopolar energy instruments. It informs customers of scenarios that may result in unintended patient harm due to capacitive coupling from monopolar energy sources.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

30 deg, 8mm Endoscope, IS4000: Model numbers: 470027-34, 470027-40, 470027-41. General and Plastic Surgery: The da Vinci Xi endoscope produces high definition (HD), visible light (VIS). The HD video is processed by the system electronics in the Vision Cart and displayed on the Surgeon Console 3D viewer and Vision Cart touchscreen. Endoscopes are available with either a 0 degree or 30 degree tips.