Patient Side Cart, REF: 380620, with instrument arms, used as part of the da Vinci X Surgical System, REF: IS4200; Patie

FDA device recall Z-1262-2023 · posted 2023-03-16 · Open, Classified

Recall details

Recalling firm

Intuitive Surgical, Inc.

Reason for recall

Preventative maintenance data was used to identify instrument Arms, part of surgical systems, that allow surgeons to perform surgical tasks, that may be at risk of insertion ballscrew failure, allowing for uncontrolled carriage movement along the insertion axis, which may cause tissue injury.

Action taken

On 01/24/2023, New Field Safety Notices were sent to customers. In addition, some customers received another notice informing them that additional preventative maintenance data would need to be collected by the recalling firm's field service personnel, to determine if additional devices were affected. On 1/27/2023, updated New Field Safety Notices were sent to two additional customers. Customers were asked to do the following: 1) Review this Field Safety Notification with all system users and place a copy of it with Instructions for use (IFU) of the system. 2) Complete and return the Acknowledgment Form via email to Recalls@intusurg.com The recalling firm will replace instrument arms found to be affected and will update the Preventive Maintenance Test to include the same analysis/method of processing Insertion Axis Friction Data that was used for determining the affected product for this Field Safety Notice so any new USM that may become susceptible will get addressed as part of the same. Customers with questions can contact customer service at: - US, Puerto Rico and Dominican Republic: (800) 876-1310, Option 3 (4 AM to 5 PM PST) or mail: customerservice@intusurg.com. - Europe, Middle East, Asia, South America and Africa: +800 0821 2020 or +41 21 821 2020 (8 AM to 6 PM CET) or EUCS@intusurg.com - South Korea: 02-3271-3200 (9 AM to 6 PM KSTJ) or support.korea@intusurg.com - Japan: 0120-56-5635 or 03-5575-1362 (9 AM to 6 PM JST) or csjapan@intusurg.com Taiwan: 886-2-2-27008181 (9am to 6:00pm CST) or CS.taiwan@intusurg.com

Root cause

Component change control

Status

Open, Classified

Product code

NAY

Quantity affected

9

Distribution

Worldwide - US Nationwide distribution in the states of FL, GA, WA and the countries of United Kingdom, Germany, France

Date initiated

2023-01-24

Date posted

2023-03-16

Location

Sunnyvale, CA

Related 510(k) clearances