{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "130164", "product_res_number": "Z-0074-2015", "event_date_initiated": "2014-09-18", "event_date_posted": "2014-10-16", "recall_status": "Terminated", "event_date_terminated": "2015-03-03", "res_event_number": "69283", "product_code": "NAY", "k_numbers": [ "K123463" ], "product_description": "EndoWrist Stapler 45 instrument for the da Vinci Si System\n\nModel Number: IS3000 \n\n\n\nProduct Usage:\nFor use with da Vinci Si System. The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as TI and T2, general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical procedures). It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.", "code_info": "EndoWrist Stapler 45 instrument, Model Number: IS3000 Part Number: PN 410298-06, -07, -08, -09 All Lots.", "firm_fei_number": "3001675293", "recalling_firm": "Intuitive Surgical, Inc.", "address_1": "1266 Kifer Rd Bldg 100 1266 Kifer Rd", "address_2": "Bldg 100", "city": "Sunnyvale", "state": "CA", "postal_code": "94086-5304", "additional_info_contact": "Mark Johnson\n408-523-2100", "reason_for_recall": "Intuitive is issuing an urgent product notice to all users of the EndoWrist Stapler 45 to discontinue use due to reports of inability to remove the stapler from tissue.", "root_cause_description": "Device Design", "action": "Intuitive Surgical sent an Urgent Product Notice letter dated September 19, 2014 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to:\n\n-Immediately stop using the EndoWrist Stapler 45 instrument.\n\n-Quarantine the EndoWrist Stapler 45 instruments within your hospital. Keep the instruments quarantined until Intuitive Surgical sends you a subsequent communication with instructions regarding the quarantined product. \n\n-Ensure all affected personnel are fully informed of this notice. Forward this notice to your Risk Manager, OR Director, Purchasing Manager, Biomedical Engineering staff, and members of your medical staff who perform da Vinci Si surgery procedures using the EndoWrist Stapler 45 instrument.\n\n-Please retain a copy of this notice for your records with your da Vinci Si User Manual.\n\nIf you need further information or support concerning this Product Notice, please contact your Clinical Sales Representative or Intuitive Surgical Customer Service at 800-876-1310 Option 3 (6 am to 5 pm PST).", "product_quantity": "1,034 Devices", "distribution_pattern": "US Nationwide Distribution.", "openfda": { "k_number": [ "K152892", "K252350", "K122532", "K211997", "K254192", "K120215", "K171120", "K171947", "K223080", "K251817", "K140189", "K233866", "K123840", "K170875", "K253986", "K242318", "K240502", "K042855", "K170713", "K191280", "K123329", "K230033", "K093217", "K121921", "K173842", "K990144", "K131962", "K210918", "K231798", "K211595", "K182140", 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