{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "211930", "product_res_number": "Z-0855-2025", "event_date_initiated": "2024-12-19", "event_date_posted": "2025-01-10", "recall_status": "Open, Classified", "res_event_number": "95938", "product_code": "NAY", "k_numbers": [ "K131861" ], "product_description": "8MM,MICRO BIPOLAR FORCEPS,IS4000 REF 470171", "code_info": "Model Number: 470171\nPart Number: 470171-15\nUDI-DI code: 00886874112274\nBatch Numbers:\nK10230801\nK10240425\nK10240613\nK10240702\nK11231116", "firm_fei_number": "3001675293", "recalling_firm": "Intuitive Surgical, Inc.", "address_1": "1266 Kifer Rd", "city": "Sunnyvale", "state": "CA", "postal_code": "94086-5304", "additional_info_contact": "Shahbaz Khan\n408-523-2443", "reason_for_recall": "Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.", "root_cause_description": "Process change control", "action": "On 12/19/2024, the firm send via email an \"Urgent: Medical Device Correction\" Letter informing customer that Intuitive Surgical has become aware of an increase in complaints regarding frayed or broken cables on some da Vinci X and Xi reusable instruments.\n\nCustomer are instructed to:\n1. Customers can continue using the products in accordance with the user manual.\n2. As a reminder, when using da Vinci X and Xi reusable instruments, follow the Inspection Before Use and Warnings listed in the manual provided with your system to inspect for any broken cables. Refer to Figures C and D for examples. In addition, please refer to Appendix B for additional images for detection of grip cable failures.\n3. If you observe any failed (frayed or broken) grip cables prior to use, during procedure, or during reprocessing, please stop use of instrument, remove from use and inform Intuitive via the standard complaint process.\n4. Inform Intuitive of any Adverse Events*/Serious Incidents** or quality problems concerning the use of the subject device via the standard complaint process.\n\nFor Question and assistance - \n\" North and South America: (800) 876-1310, Option 3 (4 am to 5 pm PST) or mail: customerservice@intusurg.com.\n\" Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 am to 6 pm CET) or eucs@intusurg.com\n\" South Korea: 02-3271-3200 (9 am to 6 pm KSTJ) or support.korea@intusurg.com\n\" Japan: 0120-56-5635 or 03-5575-1362 (9 am to 6 pm JST) or csjapan@intusurg.com\n\" India: +1-800-103-6952 (9 am to 6 pm IT)\n\" Taiwan: +0800-86-8181 (9 am to 6 pm CT)", "product_quantity": "178", "distribution_pattern": "U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico.\n\nO.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Vietnam", "openfda": { "k_number": [ "K011281", "K242427", "K151794", "K161178", "K183107", "K140553", "K161271", "K101581", "K183224", "K253986", "K192803", "K191482", "K170879", "K251324", "K212747", "K173415", "K173721", "K200049", "K043153", "K241638", "K143132", "K171699", "K040948", "K110639", "K142683", "K170641", "K122532", "K202968", "K252675", "K231798", "K152578", "K230033", "K123840", "K191280", "K050005", "K061260", "K254192", "K211316", "K191529", "K143217", "K222839", "K211325", "K171388", "K242318", "K180351", "K121921", "K171632", "K250442", "K021152", "K123329", "K070947", "K131962", "K021036", "K241284", "K150837", "K202834", "K130726", "K152448", "K162411", "K261824", "K990144", "K173906", "K170645", 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"2" } } ] }