{ "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": "2955842-2026-04245", "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": "400276", "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": "20260217", "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": [ "Erythema", "Unspecified Infection", "Blister" ] } ], "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": "24337705", "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": "393119944", "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. NOTE: REFER TO MEDWATCH REPORT (MDR) WITH MFR. REPORT # 2955842-2026-04244 FOR MDR SUBMISSION OF THE REPORTED SEROMA REQUIRING MEDICAL INTERVENTION. ." }, { "mdr_text_key": "393119945", "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-SEVEN DAYS AFTER THE INDEX PROCEDURE, THE PATIENT REPORTED A STREAK OF REDNESS ON THE LEFT BREAST. UPON EXAMINATION, AN AREA OF ERYTHEMA WITH MILD BLISTERING ADJACENT TO THE LEFT NIPPLE AREOLA COMPLEX (NAC) WAS NOTED. THE PATIENT IS CURRENTLY ON ANTIBIOTICS AND TAKING AN UNSPECIFIED TOPICAL CREAM FOR A SEROMA. THE EVENT IS ONGOING. DURING THE INDEX PROCEDURE, BILATERAL DRAINS WERE PLACED; THEY WERE REMOVED 19 DAYS AFTER SURGERY. 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 SYSTEM, NOT RELATED TO THE NSM PROCEDURE, AND NOT RELATED TO THE PATIENT'S PRE-EXISTING CONDITION." } ], "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": "" } ] }