{ "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": "2955842-2025-39008", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20251001", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20250904", "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": "20251001", "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": "1270887", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20251001", "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": "", "udi_public": "", "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": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20251022", "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": "20251001", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "32 YR", "patient_sex": "Female", "patient_weight": "82 KG", "patient_ethnicity": "Non Hispanic", "patient_race": "White", "patient_problems": [ "Burn(s)", "Burn(s)" ] } ], "distributor_city": "", "date_report": "20250905", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "23196466", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250905", "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": "381498027", "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. ADDITIONAL PATIENT INFORMATION: HEIGHT 177 CM., BODY MASS INDEX (BMI) 26.2 KG/M2." }, { "mdr_text_key": "381498028", "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. DURING THE PROCEDURE, THE PATIENT EXPERIENCED A SKIN BURN/BLISTERING ON THE RIGHT BREAST. THE COMPLICATION WAS TREATED WITH BACITRACIN ON THE WOUND AND NITRO PASTE AROUND THE WOUND. AS A RESULT, NO TISSUE EXPANDER WAS PLACED INTRA-OPERATIVELY, ONLY ACELLULAR DERMAL MATRIX. AS A RESULT, NO TISSUE EXPANDER WAS PLACED INTRA-OPERATIVELY, ONLY ACELLULAR DERMAL MATRIX. POST-OPERATIVELY, THE BILATERAL SKIN FLAPS WERE VIABLE AT THE END OF THE PROCEDURE AND A BILATERAL TWO-STAGE RECONSTRUCTION WAS PERFORMED. TISSUE EXPANDER WAS PLACED TO THE LEFT BREAST ONLY. THE STUDY INVESTIGATOR REPORTED THE EVENT AS NOT A SERIOUS ADVERSE EVENT (SAE), POSSIBLY RELATED TO DA VINCI DEVICE, POSSIBLY RELATED TO THE NSM PROCEDURE, BUT NOT RELATED TO THE RECONSTRUCTION PROCEDURE, NOT RELATED TO OTHER PROCEDURES OR EVENTS, AND NOT RELATED TO THE PATIENT'S PRE-EXISTING CONDITION. A DEVICE MALFUNCTION DID NOT RESULT IN THE 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": "" } ] }