—#122388

Product

da Vinci Si Surgical System IS3000 with the da Vinci Surgeon Console which contains a high Resolution Stereoscopic Viewer. Intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments.

FDA product code: NAY — System, Surgical, Computer Controlled Instrument
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K081137
Affected lot / code info: model numbers 380610-04 through 38-610-14.

Why it was recalled

Improper restraints during transportation of the da Vinci system could cause the HRSV Monitor to become loose from its mount.

Root cause (FDA determination)

Use error

Action the firm took

Advisory letters were sent to all affected customers on 10/17/11 informing them to contact Customer Service prior to moving the system outside of the hospital.

Recalling firm

Firm: Intuitive Surgical, Inc.
Address: 1266 Kifer Rd, Bldg 100, Sunnyvale, California 94086-5304

Distribution

Distribution pattern: Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Austria, Belgium, Canada, Chile, China, Denmark, Egypt, Finland, France, Greece, Germany, India, Indonesia, Israel, Ireland, Italy, Kuwait, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, and United Kingdom.

Timeline

Recall initiated: 2011-10-17
Posted by FDA: 2013-10-28
Terminated: 2013-10-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #122388. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.