Recall Z-1897-2020— Intuitive Surgical Inc

Name: FDA recall Z-1897-2020
Creator: U.S. Food and Drug Administration
Published: 2019-04-11

Class II · Terminated

Class II FDA medical device recall by Intuitive Surgical Inc, initiated 2019-04-11, terminated 2024-04-08. It names one FDA 510(k) clearance: K171294. Product: da Vinci X Surgical System, IS4200 - Product Usage: The da Vinci Xi surgical system (IS4000) 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 IS4000 system and its primary function is to support the instrument arms and camera arm. The system has four Universal Surgical Manipulators (USM) also known as arms, which allow the surgeon to control up to three instruments and an endoscope simultaneously to perform surgical tasks (e.g. cutting, suturing, tissue approximation) in a variety of procedures. There are four USM per da Vinci X surgical system.. Reason: Failure of Universal Surgical Manipulators due to a high friction points, resulting in an increase of arm movement to include: feelings of resistance, hesitation, and jerking..

Recalling firm: Intuitive Surgical Inc
Classification: Class II
Status: Terminated
Initiated: 2019-04-11
Terminated: 2024-04-08
Firm location: Sunnyvale, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K171294 — da Vinci X Surgical SystemIntuitive Surgical, Inc.·cleared 2017-05-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

da Vinci X Surgical System, IS4200 - Product Usage: The da Vinci Xi surgical system (IS4000) 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 IS4000 system and its primary function is to support the instrument arms and camera arm. The system has four Universal Surgical Manipulators (USM) also known as arms, which allow the surgeon to control up to three instruments and an endoscope simultaneously to perform surgical tasks (e.g. cutting, suturing, tissue approximation) in a variety of procedures. There are four USM per da Vinci X surgical system.

Reason for recall

Failure of Universal Surgical Manipulators due to a high friction points, resulting in an increase of arm movement to include: feelings of resistance, hesitation, and jerking.

Data sourced from openFDA. This site is unofficial and independent of the FDA.