FDA-Device2020-02-05Class II
The da Vinci SP surgical system is made of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart is the operative component of the SP system and its primary function is to support the positioning of the surgical port (cannula) and to manipulate the surgical instruments and camera. The Model Number is SP 1098.
Intuitive Surgical, Inc.
Hazard
The firm became aware of a problem with the surgical system where the cannula mount button may be damaged when the user releases the button abruptly.
Sold states
Product distributed in the US to the following states: Minnesota, New York, Ohio, and Pennsylvania.
Affected count
5 PSCs (Units)
Manufactured in
1266 Kifer Rd Bldg 101, N/A, Sunnyvale, CA, United States
Products
The da Vinci SP surgical system is made of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart is the operative component of the SP system and its primary function is to support the positioning of the surgical port (cannula) and to manipulate the surgical instruments and camera. The Model Number is SP 1098.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0845-2020Don't want to check this manually?
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