{ "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": "2955842-2025-17424", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20250509", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20250407", "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", "Study", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20250509", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20190904", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2181612", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250509", "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": "380601-34", "catalog_number": "380601", "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": "FL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250825", "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": "20250509", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "56 YR", "patient_sex": "Female", "patient_weight": "58 KG", "patient_ethnicity": "Non Hispanic", "patient_race": "Black Or African American", "patient_problems": [ "Ischemia", "Ischemia" ] } ], "distributor_city": "", "date_report": "20250411", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "21996115", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250411", "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": "369940405", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A PATIENT WHO WAS ENROLLED IN A STUDY, UNDERWENT A DA VINCI-ASSISTED NIPPLE SPARING MASTECTOMY SURGICAL PROCEDURE. DURING THE PROCEDURE, AN AREA OF ISCHEMIA WAS OBSERVED ON THE LEFT BREAST INFERIOR TO THE NIPPLE AREOLA COMPLEX (NAC). THE AREA WAS COVERED WITH SILVADENE CREAM. THE SKIN ISCHEMIA WILL BE SUBJECT TO OBSERVATION AND THE PATIENT WAS CONNECTED WITH ANOTHER INSTITUTION FOR POSSIBLE TREATMENT WITH HYPERBARIC OXYGEN THERAPY. THE PATIENT WAS DISCHARGED THE SAME DAY, THE EVENT IS REPORTED AS ONGOING AND THE PATIENT WILL RETURN IN A FEW WEEKS FOR A RE-EVALUATION AND PROCEED WITH RECONSTRUCTION. THERE WAS NO REPORT OF A DA VINCI DEVICE MALFUNCTION DURING THE PROCEDURE. THE STUDY INVESTIGATOR INDICATED THAT THERE WERE NO INTRAOPERATIVE DEVICE MALFUNCTIONS AND THE INJURY WAS OBSERVED AFTER DOCKING OF THE SYSTEM. THE EVENT WAS REPORTED AS MODERATE SEVERITY, POSSIBLY RELATED TO THE DA VINCI SYSTEM, POSSIBLY RELATED TO THE NSM PROCEDURE, BUT NOT RELATED TO RECONSTRUCTION, AND NOT RELATED TO THE PATIENT'S PRE-EXISTING CONDITION. THE STUDY INVESTIGATOR STATED THERE WAS NO ARCING OR SPARKING COMING FROM ANY OF THE INSTRUMENTS AND THAT THE PATIENT WAS CONNECTED WITH ANOTHER FACILITY FOR HYPERBARIC OXYGEN CHAMBER TREATMENT WHICH WAS ADMINISTERED FOR 10 DAYS. THE SURGEON BELIEVES THE COMPLICATION OCCURRED SINCE THE FLAP WAS TOO THIN." }, { "mdr_text_key": "369940406", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THERE WAS NO REPORT THAT A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY MALFUNCTIONED DURING THE PROCEDURE. INVESTIGATION REVEALED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT." } ], "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": "" } ] }