Device 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.
Z-0088-2014
Product summary
- Event
- Event 66434
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,090 consoles
- Official record key
device-enforcement:Z-0088-2014
Official wording
Reason: Improper restraints during transportation of the da Vinci system could cause the HRSV Monitor to become loose from its mount.
Code information: model numbers 380610-04 through 38-610-14.
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.
Derived failure modes
-
Unknown
Improper restraints during transportation of the da Vinci system could cause the HRSV Monitor to become loose from its mount.