{ "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": "2026-09-08", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "N", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Death", "report_number": "MW5164582", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20250110", "manufacturer_address_2": "", "pma_pmn_number": "", "reprocessed_and_reused_flag": "", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20250113", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "682533", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250110", "brand_name": "DA VINCI SURGICAL SYSTEM", "generic_name": "SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT", "manufacturer_d_name": "INTUITIVE SURGICAL, INC.", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "", "manufacturer_d_state": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "", "model_number": "", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No answer provided", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250820", "health_professional": "*", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20250110", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Insufficient Information", "Insufficient Information" ] } ], "distributor_city": "", "date_report": "20250110", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "21138441", "removal_correction_number": "", "number_devices_in_event": "", "manufacturer_name": "", "report_source_code": "Voluntary report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "361203072", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "DRS. (B)(6), PLEASE NOTE, MS. (B)(6), WHO DIED WITHIN ONE YEAR FOLLOWING ROBOTIC MASTECTOMY FOR STAGE 2 BREAST CANCER: PLEASE NOTE - MS. (B)(6) CASE WAS ADVERTISED AS THE FIRST ROBOTIC MASTECTOMY OPERATION PERFORMED IN THE U.S. FOR TREATMENT OF BREAST CANCER: PLEASE NOTE, 5-YR SURVIVAL RATES FOR STAGE 2 BREAST CANCER USING THE CONVENTIONAL APPROACH TO MASTECTOMY IS OVER 80%. MS. (B)(6) DIED WITHIN ONE YEAR OF HER ROBOTIC MASTECTOMY SURGERY. PLEASE ENSURE THAT INTUITIVE SURGICAL HAS FORMALLY REPORTED THIS PATIENT MORTALITY FOLLOWING HER ROBOTIC MASTECTOMY TO THE FDA. ON JAN 5, 2025, AT 11:37 PM, (B)(6) WROTE: DRS. (B)(6), I AM WRITING THIS LETTER OF SAFETY AND ETHICS CONCERN/WARNING TO YOU BASED ON THE TWO RECENT HUMAN SUBJECT RESEARCH PUBLICATIONS FROM SOUTH KOREA, WHICH WERE SUPPORTED BY INTUITIVE SURGICAL: HTTPS://JAMANETWORK.COM/JOURNALS/JAMASURGERY/FULLARTICLE/2822315, HTTPS://WWW.NATURE.COM/ARTICLES/S41598-024-84807-0. THESE STUDIES INVOLVE THE USE OF THE DA VINCI ROBOTIC SYSTEM TO PERFORM MASTECTOMIES ON PATIENTS WITH BREAST CANCER, WHICH AS YOU KNOW WELL, IS CONSIDERED A NON-STANDARD AND OFF-LABEL APPROACH IN THE US AND WESTERN EUROPE. ADDITIONALLY, THESE EXPERIMENTAL SURGERIES WERE PERFORMED OUTSIDE OF A PROPERLY DESIGNED PROSPECTIVE CLINICAL TRIAL DESIGNED TO ESTABLISH ONCOLOGICAL NONINFERIORITY OF THIS NEW APPROACH TO MASTECTOMY FOR BREAST CANCER TREATMENT. IN BOTH THESE STUDIES INTUITIVE'S S. KOREAN PROXIES PERFORMED THIS EXPERIMENTAL ROBOTIC SURGICAL PROCEDURE ON WOMEN WITH BREAST CANCER - AND IN DIRECT BREACH OF THE WELL-ESTABLISHED STANDARD OF CARE FOR SURGICAL EXCISION OF BREAST CANCER. BOTH STUDIES EXPLICITLY STATE THEIR ANALYSES ARE \"RETROSPECTIVE\" - DESPITE THE FACT THAT PERFORMING THE QUITE SUBSTANTIAL NUMBER OF ROBOTIC MASTECTOMIES, DESCRIBED IN THESE PAPERS, REQUIRES EXTENSIVE \"PROSPECTIVE\" PLANNING. THUS, TO HAVE PERFORMED AS MANY ROBOTIC MASTECTOMIES AS THESE S. KOREAN SURGEONS DID PERFORM, OUTSIDE OF A PROPER PROSPECTIVE CLINICAL TRIAL SETTING, RAISES A MAJOR ETHICAL RED FLAG IN ANY REASONABLE HUMAN SUBJECT EXPERIMENTAL SETTING. IT IS ALMOST CERTAIN THAT THIS TRANSPARENT USE OF THE \"RETROSPECTIVE\" RUBRIC WAS INTENTIONALLY AIMED AT SKIRTING A ETHICALLY PROPER, WELL-DESIGNED AND ADEQUATELY POWERED PROSPECTIVE TRIAL TO ESTABLISH ONCOLOGICAL NON-INFERIORITY. WITH THIS LETTER, I AM INFORMING YOU THAT YOUR S. KOREAN COLLABORATORS' USE OF A \"RETROSPECTIVE STUDY\" RUBRIC IN DESCRIBING THESE PUBLICATIONS IS LIKELY TO BE DECEPTIVE AND ETHICALLY PROBLEMATIC - BY EXTENSION, INTUITIVE SURGICAL'S FINANCIAL SUPPORT OF THESE STUDIES OUGHT TO BE CAUSE FOR SIGNIFICANT CONCERN BY YOUR COMPANY AND ITS EXECUTIVES AND INVESTORS. SPECIFICALLY, BECAUSE IN NEITHER OF THE ABOVE REFERENCED STUDIES IS THERE ANY INDICATION AS TO WHETHER THE ROBOTIC MASTECTOMY OPERATIONS PERFORMED IN S. KOREA WERE DONE WITH PROPER INFORMED CONSENT TO THE PATIENTS ABOUT THE FACTS THAT: 1) THIS NEW APPROACH TO BREAST CANCER TREATMENT IS 100% EXPERIMENTAL, 2) ITS ONCOLOGICAL SAFETY OR EFFICACY HAS NOT BEEN ESTABLISHED, OR 3) THE ROBOTIC APPROACH TO MASTECTOMY FOR TREATMENT OF BREAST CANCER MAY BE ONCOLOGICALLY INFERIOR TO THE CONVENTIONAL APPROACH." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }