FDA-Device2015-03-11Class II
Vacuum Source Tubing Set for the EndoWrist Stabilizer for da Vinci S (IS2000) and Si (IS3000); Part number 420187-05. The Intuitive Surgical EndoWrist Stabilizer Instrument is intended to be used with the fourth arm of the da Vinci S Surgical System. The Intuitive Surgical EndoWrist Stabilizer Instrument is intended to stabilize the epicardial surface of the non-arrested heart during coronary artery surgery.
Intuitive Surgical, Inc.
Hazard
There is the possibility that the Vacuum Source Tubing set for the Endo Wrist Stabilizer may have the outer pouch compromised during shipping, resulting in small pinholes which compromise the sterility of the pouches outer surface.
Sold states
US and Belgium, Brazil, Canada, China, Finland, France, Greece, India, Italy, Japan, Qatar, Russia, Saudi Arabia, South Korea, Spain, Switzerland, Taiwan, Turkey, United Kingdom
Affected count
706 units
Manufactured in
1266 Kifer Rd Bldg 100, N/A, Sunnyvale, CA, United States
Products
Vacuum Source Tubing Set for the EndoWrist Stabilizer for da Vinci S (IS2000) and Si (IS3000); Part number 420187-05. The Intuitive Surgical EndoWrist Stabilizer Instrument is intended to be used with the fourth arm of the da Vinci S Surgical System. The Intuitive Surgical EndoWrist Stabilizer Instrument is intended to stabilize the epicardial surface of the non-arrested heart during coronary artery surgery.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1226-2015Don't want to check this manually?
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