{ "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": "2955842-2026-04244", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20260213", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20251210", "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": "", "date_added": "20260213", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20200504", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "399292", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260213", "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": "380601-40", "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" ], "reporter_state_code": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20260429", "health_professional": "Y", "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": "20260213", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "37 YR", "patient_sex": "Female", "patient_weight": "57 KG", "patient_ethnicity": "", "patient_race": "White", "patient_problems": [ "Unspecified Infection", "Seroma" ] } ], "distributor_city": "", "date_report": "20260213", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "24336895", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20260122", "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": "393116374", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A PATIENT IN A STUDY UNDERWENT A DA VINCI ASSISTED BILATERAL NIPPLE SPARING MASTECTOMY (NSM) PROCEDURE. THIRTY-SIX DAYS AFTER THE PROCEDURE, THE PATIENT REPORTED FLUID FROM THE LEFT NIPPLE; ANTIBIOTICS WERE PRESCRIBED. THE NEXT DAY, THE PRIMARY INVESTIGATOR DISCUSSED WITH THE PATIENT THAT EXPLANTATION MAY BE REQUIRED IF THE SEROMA CONTINUED. THE EVENT WAS REPORTED AS ONGOING. DURING THE INDEX PROCEDURE, BILATERAL DRAINS WERE PLACED; THEY WERE REMOVED 19 DAYS AFTER THE PROCEDURE. THE BILATERAL SKIN FLAPS WERE VIABLE AT THE END OF THE NSM AND RECONSTRUCTION PROCEDURE; A TWO-STAGE RECONSTRUCTION WAS PLANNED. THERE WERE NO INTRA-OPERATIVE OR POST-OPERATIVE COMPLICATIONS. DISCHARGE OCCURRED TWO DAYS AFTER THE INDEX PROCEDURE. THERE WERE NO DA VINCI DEVICE MALFUNCTIONS DURING THE PROCEDURE. THE STUDY INVESTIGATOR REPORTED THE EVENT AS MILD SEVERITY, NOT A SERIOUS ADVERSE EVENT, A CLAVIEN-DINDO GRADE II, POSSIBLY RELATED TO THE RECONSTRUCTION PROCEDURE, BUT NOT RELATED TO THE DA VINCI DEVICE AND NOT RELATED TO THE NSM PROCEDURE, AND NOT RELATED TO THE PATIENT'S PRE-EXISTING CONDITION." }, { "mdr_text_key": "393116375", "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. ADDITIONAL PATIENT INFORMATION: HEIGHT 162.6 CM." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }