{ "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": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "SANTA CLARA", "manufacturer_contact_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_contact_pcity": "40852321", "event_type": "Injury", "report_number": "2955842-2025-00831", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20250128", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20250102", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Literature", "Health Professional", "User facility" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "", "manufacturer_contact_area_code": "408", "date_added": "20250128", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20220907", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "461132", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250128", "brand_name": "DA VINCI SP", "generic_name": "PATIENT SIDE CART", "manufacturer_d_name": "INTUITIVE SURGICAL, INC", "manufacturer_d_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_d_address_2": "", "manufacturer_d_city": "SANTA CLARA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "95051", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95051", "device_operator": "HEALTH PROFESSIONAL", "model_number": "380601-45", "catalog_number": "N/A", "lot_number": "N/A", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "N", "combination_product_flag": "N", "udi_di": "00886874114605", "udi_public": "(01)00886874114605", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250822", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "4085", "patient": [ { "patient_sequence_number": "1", "date_received": "20250128", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention", " H" ], "patient_age": "47 YR", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hematoma", "Hemorrhage/Blood Loss/Bleeding", "Necrosis", "Hematoma", "Hemorrhage/Blood Loss/Bleeding", "Necrosis" ] } ], "distributor_city": "", "date_report": "20250105", "initial_report_to_fda": "Yes", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "21253205", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250105", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "95051", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "INTUITIVE SURGICAL, INC", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "362301740", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "NO INVESTIGATION COULD BE PERFORMED AS THE ARTICLE DID NOT PROVIDE ANY SPECIFIC INFORMATION REGARDING THE PROCEDURE DATE OR DA VINCI SYSTEM IDENTIFIERS. THERE WAS NO REPORT OF, OR INDICATION OF, ANY DA VINCI PRODUCT ISSUES. THERE IS NO INDICATION THAT ANY DA VINCI PRODUCTS CONTRIBUTED TO THE REPORTED COMPLICATIONS. SOURCE: LEE, S.B., KIM, J., CHUNG, I.Y. ET AL. USE OF THE DA VINCI SP SURGICAL SYSTEM IN ROBOT-ASSISTED NIPPLE-SPARING MASTECTOMY: A SINGLE-CENTER, RETROSPECTIVE STUDY. SCI REP 15, 12 (2025). HTTPS://DOI.ORG/10.1038/S41598-024-84807-0. SECTION A: PATIENT INFORMATION - NO SPECIFIC PATIENT DEMOGRAPHICS WERE PROVIDED FOR THE PATIENTS EXPERIENCED COMPLICATIONS. THE MEAN AGE OF THE TOTAL PATIENTS IS 47 YEARS. FIELD B3: DUE TO THE LACK OF SPECIFIC INFORMATION REGARDING THE EVENT DATE ASSOCIATED WITH THE ADVERSE EVENT, AN ALTERNATE DATE, PUBLISHED DATE HAS BEEN USED." }, { "mdr_text_key": "362301741", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A LITERATURE ARTICLE WAS REVIEWED THAT DESCRIBED A RETROSPECTIVE ANALYSIS THE SAFETY AND PERFORMANCE OF THE DA VINCI SINGLE-PORT SYSTEM IN NIPPLE SPARING MASTECTOMY (NSM) WITH IMMEDIATE RECONSTRUCTION BETWEEN OCTOBER 2020 AND AUGUST 2021 IN ONE SINGLE INSTITUTION. A TOTAL OF 60 PATIENTS DIAGNOSED WITH BREAST CANCER WERE INCLUDED; 53.3% OF THE PATIENTS HAD INVASIVE DUCTAL CARCINOMA. ALL PROCEDURES WERE COMPLETED WITH NO CONVERSION TO MULTIPORT OR OPEN SURGERY REQUIRED. THE ARTICLE DOCUMENTS THAT NO INTRAOPERATIVE ADVERSE EVENTS WERE REPORTED. AMONG THE SIXTY PATIENTS, ONE PATIENT EXPERIENCED HYPOTENSION AND WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) POSTOPERATIVELY FOR ONE DAY DUE TO A BLOOD PRESSURE DROP FROM INTRAOPERATIVE BLEEDING. TWELVE PATIENTS EXPERIENCED POST-OPERATIVE COMPLICATIONS: FIVE DEVELOPED NIPPLE-AREOLAR COMPLEX (NAC) NECROSIS, SIX DEVELOPED HEMATOMAS AND ONE DEVELOPED A PNEUMOTHORAX. AMONG THE PATIENTS THAT EXPERIENCED POST-OPERATIVE COMPLICATIONS, THREE REQUIRED RE-OPERATION WITHIN A MONTH AFTER SURGERY: TWO WERE FOR SURGICAL SITE HEMATOMAS, AND ONE REQUIRED OPEN SURGERY FOR WOUND DEBRIDEMENT. NO DA VINCI DEVICE MALFUNCTIONS WERE REPORTED, AND THE AUTHORS DID NOT ALLEGE THAT INTUITIVE SURGICAL, INC. (ISI) PRODUCTS CAUSED OR CONTRIBUTED TO ANY ADVERSE EVENT." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }