Device product
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.
Z-0845-2020
Product summary
- Event
- Event 83192
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5 PSCs (Units)
- Official record key
device-enforcement:Z-0845-2020
Official wording
Reason: 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.
Code information: The Affected Systems are : SP0022, SP0023, SP0024, SP0025 and SP0026.
Distribution pattern: Product distributed in the US to the following states: Minnesota, New York, Ohio, and Pennsylvania.
Derived failure modes
-
Unknown
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.