FDA-Device2015-06-24Class II

Thoracic Grasper, 5 MM, for use with da Vinci S (IS2000) and SI (IS3000) Surgical Systems. Intended for endoscopic manipulation of tissue, including grasping.

Intuitive Surgical, Inc.
Hazard

The coating of the 5 mm Thoracic Grasper main tube may experience damage with the possibility of fragments of coating material dislodging and potentially falling into patient.

Sold states
Worldwide Distribution -- US, Belgium, Brazil, Canada, Chile, Colombia,, Denmark, France, Germany, India, Netherlands, Panama, Singapore, South Korea, Switzerland, Taiwan, Turkey, and United Kingdom.
Affected count
2,436 units
Manufactured in
1266 Kifer Rd Bldg 100, Sunnyvale, CA, United States
Products
Thoracic Grasper, 5 MM, for use with da Vinci S (IS2000) and SI (IS3000) Surgical Systems. Intended for endoscopic manipulation of tissue, including grasping.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1812-2015

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