Intuitive Surgical, Inc.: Da Vinci S/Si Large Clip Applier, Model 420230 Da Vinci S/Si Medium-Large Clip Applier, Model 420327 Da Vinci S/Si Small Clip Applier, Model 420003

Recall number

Z-1459-2022

Recalling firm

Intuitive Surgical, Inc.

Product

Da Vinci S/Si Large Clip Applier, Model 420230 Da Vinci S/Si Medium-Large Clip Applier, Model 420327 Da Vinci S/Si Small Clip Applier, Model 420003

Status

Open, Classified

Initiated

2022-07-01

Posted

not on file

Terminated

not on file

Reason

Due to the potential for unexpected motion caused by the partial disengagement of the instrument from the system.

Root cause

Nonconforming Material/Component

Action

On 07/01/2022, Intuitive Surgical sent an "Urgent Medical Device Correction" Letter to customers via FedEx courier informing them there is the potential for unexpected motion while using the da Vinci S/Si and X/Xi Endowrist Clip Applier Instruments. This can happen when one of the da Vinci S/Si and X/Xi Clip Applier grip discs are disengaged from the sterile adapter disc during the engagement routine that occurs prior to insertion of the instrument into the cannula and into the patient. To mitigate this issue, Intuitive Surgical has developed a Clip Applier Manual Self-Test (Appendix A) that is part of the Urgent Medical Device Correction Letter. This test is performed by moving the Clip Applier grips through the full range of yaw motion (side-to-side in the plane of the instrument grips) and observing the movement of both the instrument grips prior to placing a clip around a vessel/tissue. This test should be performed in an open space to prevent any collisions. Pass Criteria " During the yaw movement, if the grips remain open with no observation of grips closing then the instrument passes the self-test and users may proceed with using the clip applier instrument in a procedure. Fail Criteria " During yaw movement, if the grips begin to close as opposed to the grips remaining open then there is potential that one of the grip discs is not engaged. Instrument should be removed, reinstalled, and inspected for engagement. If the self- test fails, remove Clip Applier instrument, re-install and repeat self-test. If it fails again, use a different Clip Applier instrument and return the instrument using the standard Intuitive RMA process. Please call customer service to return the affected product using the appropriate local number listed in section 6 of the letter. Credit will be issued when the reported unexpected motion is confirmed. For questions: " US, Puerto Rico and Dominican Republic: (800) 876-1310, Option 3 (4 AM to 5 PM PST) or mail: customerservice@intusurg

Quantity

62,895 Clip appliers

Distribution

Worldwide distribution - U.S. Nationwide distribution in the states of AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY. The countries of Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.

Lot, serial or model codes

Model/Model Number/UDI Number Da Vinci S/Si Large Clip Applier / 420230 / 00886874111680 Da Vinci S/Si Medium-Large Clip Applier / 420327 / 00886874111826 Da Vinci S/Si Small Clip Applier / 420003 / 00886874111161 Serial Numbers: All

510(k) numbers

["K050369"]

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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