Intuitive Surgical Inc: 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.

Recall number

Z-1897-2020

Recalling firm

Intuitive Surgical Inc

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.

Status

Terminated

Initiated

2019-04-11

Posted

not on file

Terminated

2024-04-08

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.

Root cause

Process control

Action

On 04/11/2019, the firm sent an "Urgent Medical Device Correction" notifications via FedEx to its customers informing them that the Recalling Firm has become aware that specific Surgical Systems arms have the potential to encounter friction in specific instrument arm orientations. As a result, sluggish, jerky, or hesitating motion may be experienced at the instrument tip and/or resistance felt in the hand controls. To correct this issue, a Recalling Firm's representative will schedule a site visit to perform evaluations on their systems. Based on the results of the evaluation, any necessary corrections will be prioritized appropriately. In addition: Customers are informed and instructed that If any of instruments arms exhibit sluggish, jerky, or hesitating motion, or if you feel significant resistance from the hand controls with no interference between arms/instruments, contact the da Vinci Surgical Technical Assistance Team (dVSTAT) as soon as possible. General Acknowledgement 1. Forward this letter to your Risk Manager, OR Director, Biomedical Engineering staff, and other members of your medical staff who perform da Vinci procedures. 2. If available, please log into the da Vinci Online Community Field Action resource to read or complete any requested actions related to this issue, at this link: https://www.davincisurgerycommunity.com/ 3. In the event the da Vinci online resource cannot be used, complete the attached Acknowledgement Form and return it via fax to Intuitive as instructed on the form. 4. Please retain a copy of this letter and the acknowledgement form for your files. representatives will be available by phone to answer any questions related to this Medical Device Correction. An Intuitive representative will schedule a site visit with your hospital to perform the inspection and provide any potential correction activity for the instrument arms of your system(s). If you need further information or support concerning this Medical Devic

Quantity

270 USMs on a combination of 100 unique systems (4 USM per system)

Distribution

Worldwide distribution - US Nationwide distribution including in the states of AK, AZ, CA, CO, CT, District of Columbia, FL, GA, IL, IN, IA, KS. MA, MI, MS, NB, NY, OH, PA, TN, TX, VA, WA and WI and the countries of Australia, Belgium, Brazil, France, Germany, India, Italy, Japan, South Korea, Spain, Sweden, and the United Kingdom.

Lot, serial or model codes

UDI: 00886874114216 Device Listing: D295931 Serial Numbers: SL0085, SL0315, SL0317, SL0324, SL0338, SL0350, SL0351, SL0353, SL0354, SL0357, SL0369

510(k) numbers

["K171294"]

PMA numbers

not on file

Product code

NAY

Firm FEI

3001675293

Firm city

Sunnyvale

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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