{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "194147", "product_res_number": "Z-1459-2022", "event_date_initiated": "2022-07-01", "event_date_created": "2022-07-25", "recall_status": "Open, Classified", "res_event_number": "90332", "product_code": "NAY", "k_numbers": [ "K050369" ], "product_description": "Da Vinci S/Si Large Clip Applier, Model 420230\nDa Vinci S/Si Medium-Large Clip Applier, Model 420327\nDa Vinci S/Si Small Clip Applier, Model 420003", "code_info": "Model/Model Number/UDI Number\nDa Vinci S/Si Large Clip Applier / 420230 / 00886874111680\nDa Vinci S/Si Medium-Large Clip Applier / 420327 / 00886874111826\nDa Vinci S/Si Small Clip Applier / 420003 / 00886874111161\n\nSerial Numbers: All", "firm_fei_number": "3001675293", "recalling_firm": "Intuitive Surgical, Inc.", "address_1": "1266 Kifer Rd Bldg 101 1266 Kifer Rd", "address_2": "Bldg 101", "city": "Sunnyvale", "state": "CA", "postal_code": "94086-5304", "additional_info_contact": "Alex Mathews\n408-523-2100", "reason_for_recall": "Due to the potential for unexpected motion caused by the partial disengagement of the instrument from the system.", "root_cause_description": "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.\n\nTo 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.\nPass Criteria\n\" 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.\nFail Criteria\n\" 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.\nIf 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.\n\nFor questions:\n\" US, Puerto Rico and Dominican Republic: (800) 876-1310, Option 3 (4 AM to 5 PM PST) or mail: customerservice@intusurg", "product_quantity": "62,895 Clip appliers", "distribution_pattern": "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\nIslands, 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.", "openfda": { "k_number": [ "K011002", "K150837", "K250674", "K180163", "K252675", "K260695", "K022574", "K090993", "K131962", "K202571", "K200049", "K192717", "K173721", "K070947", "K232610", "K173585", "K170875", "K191736", "K063220", "K183086", "K222839", "K162411", 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