{ "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": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "190985", "product_res_number": "Z-0702-2022", "event_date_initiated": "2021-12-23", "event_date_created": "2022-03-01", "recall_status": "Open, Classified", "res_event_number": "89274", "product_code": "NAY", "k_numbers": [ "K140553", "K162411" ], "product_description": "da Vinci Xi and X 12-8 mm Conductive Cannula Reducer, REF: 470381-11", "code_info": "UDI: 00886874112588\nL10210114\nL10210115\nL10210122\nL10210125\nL10210128\nL10210204\nL10210205\nL10210211\nL10210212\nL10210215\nL10210216\nL10210217\nL10210218\nL10210219\nL10210225\nL10210226\nL10210301\nL10210304\nL10210305\nL10210308\nL10210309\nL10210316\nL10210317\nL10210318\nL10210321\nL10210322\nL10210513\nL10210514\nL10210520\nL10210521\nL10210527\nL10210528\nL10210529\nL10210715\nL10210716\nL10210717\nL10210718\nL10210719\nL10210720\nL10210722\nL10210723\nL10210731\nL10210801\nL10210803\nL10210805\nL10210806\nL10210807\nL10210808\nL10210809\nL10210812\nL10210813\nL10210819\nL10210924\nL10210925\nL10210926\nL10210930\nL11210111\nL11210316\nM10210330\nM10210331\nM10210405\nM10210408\nM10210409\nM10210412\nM10210415\nM10210416\nM10210422\nM10210423 \nM10210429 \nM10210430", "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": "408-523-2100", "reason_for_recall": "Conductive Cannula Reducer metal tip may get dislodged from the plastic shaft. If unnoticed, additional surgery may be required to remove the metal tip. If the procedure proceeds without the metal tip, there is potential for energy leakage, which could cause tissue damage. If the metal tip remains in the patient, adhesions may form, which may lead to bowel obstruction and chronic abdominal pain.", "root_cause_description": "Nonconforming Material/Component", "action": "On 12/23/21 recall notices were mailed to customers who were asked to do the following:\n1. Inform necessary hospital personnel about this issue.\n2. Locate all affected devices at your site and return to the recalling firm.\n3. Inform affected personnel when the requested actions have been completed.\n4. Complete and return the attached Acknowledgement Form\n5. Please retain a copy of this letter and the acknowledgement form for your files.\nIf you need further information or support contact your Clinical Sales Representative or contact Intuitive Customer Service: \nNorth and South America: (800) 876-1310, Option 3 (4 AM to 5 PM PST) or mail: customerservice@intusurg.com\nEurope, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 AM to 6 PM CET) or EUCS@instusurg.com\nSouth Korea: 02-3271-3200 (9 AM to 6 PM KSTJ) or support.korea@intusurg.com\nJapan: 0120-56-5635 or 03-5575-1362 (9 AM to 6 PM JST) or csjapan@intusurg.com\nTaiwan: 886-2-27008181 (7:30am to 5:30pm CT) or CS.Taiwan@intusurg.com\n\nDistributors were asked to provide their customers with the information found in the recall notice; the notice the recalling firm sent to their customers was included as an attachment. Distributors are to collect the affected cannula reducers and return them to the recalling firm. Distributors were asked to complete and return a recall response form. They were also asked to follow-up with their customers who don't respond to the recall notice at least three times.", "product_quantity": "149,646 reducers", "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of California, Wisconsin, Virginia, Ohio, Texas, New York, Nevada, Connecticut, New Jersey, Massachusetts, Georgia, Florida, Indiana, North Carolina, Missouri, Pennsylvania, Michigan, Oregon, Kentucky, Hawaii, Tennessee, Alabama, Nebraska, Maryland, Oklahoma, Colorado, Arkansas, Arizona, Kansas, Illinois, South Carolina, Minnesota, North Dakota, Iowa, Louisiana, Washington, Delaware, Mississippi, New Mexico, District of Columbia, Idaho, New Hampshire, Rhode Island, West Virginia, South Dakota, Alaska, Maine, Utah, Montana, Vermont, Wyoming, Puerto Rico and the countries of Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Luxembourg, Martinique, Monaco, Netherlands, Norway, Poland, Qatar, Reunion, Romania, Saudi Arabia, Singapore, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom.", "openfda": { "k_number": [ "K251324", "K183107", "K170879", "K183098", "K191280", "K011281", "K112263", "K131861", "K211316", "K173721", "K123463", "K240723", "K012833", "K152892", "K153276", "K200473", "K130266", "K150284", "K192877", "K182371", "K212747", "K250786", "K203632", "K021036", "K043153", "K161271", "K042855", "K233866", "K050005", "K162973", "K143132", "K254192", "K180163", "K202834", "K141077", "K061260", "K173585", "K173337", "K214095", "K123840", "K002489", "K070947", "K170875", "K182421", "K220889", "K241638", "K060391", "K152448", "K223095", "K192803", "K170644", "K141075", "K140553", "K192717", "K050802", "K170645", "K243714", "K072627", "K011002", "K990144", "K212101", "K211784", "K162411", "K183086", "K183224", "K182140", "K243582", "K251202", "K251426", "K112208", "K030578", 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"K242318", "K172643", "K213710" ], "registration_number": [ "2955842", "3011459762", "3015612252", "3031594238", "3002259632", "3017619652", "3017119401", "3007303113", "3015224777", "3010157088", "3014309390", "8043980", "2246552", "3004111573", "3007111496", "3014656892", "3015153469", "3010493171", "3001556604", "9611665", "3010860245", "3014635169", "3013868968", "3013665681", "3009161688", "2029015", "1226146", "1531174", "3013077751", "3048246462", "9616517", "3042940623", "2029275", "3012811961", "3003537036", "3001592626", "3014663814", "3017636737", "3015241782", "1058584", "3014579024", "3001675293", "3033043422", "3026606306", "2011171", "3004784537", "3007029079", "3015895145", "3005369776", "3010193531", "3010885402", "3016079756", "3016607092", "3013188547", "2022435", "3014644276", "3020331900", "3009941480", "3042953929", "3044545674", "3011063460", "3010564249", "3036035332", "1061124", "9614969", "3022626486", "8043903", "3018126215", "3012453745", "8010456", 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