FDA recall Z-0845-2020

Intuitive Surgical, Inc. · Class II · 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.

Reason for recall

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.

Distribution

Product distributed in the US to the following states: Minnesota, New York, Ohio, and Pennsylvania.

Key facts

Status
Terminated
Initiation date
2018-10-23
Report date
2020-02-05
Termination date
2022-01-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Sunnyvale, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0845-2020