{ "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": "2955842-2024-19085", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20240906", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20240712", "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": "20240906", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20220301", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1835035", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240906", "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": "PA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250820", "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": "20240906", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention", " H" ], "patient_age": "37 YR", "patient_sex": "Female", "patient_weight": "72 KG", "patient_ethnicity": "Non Hispanic", "patient_race": "", "patient_problems": [ "Seroma", "Seroma" ] } ], "distributor_city": "", "date_report": "20240813", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "20158910", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20240813", "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": "351147596", "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. A SYSTEM LOG REVIEW COULD NOT BE PERFORMED BECAUSE THE SYSTEM LOGS WERE NOT AVAILABLE." }, { "mdr_text_key": "351147597", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT A PATIENT ENROLLED IN A STUDY, UNDERWENT A DA VINCI-ASSISTED NIPPLE SPARING MASTECTOMY SURGICAL PROCEDURE. APPROXIMATELY THREE WEEKS LATER, HOME HEALTH VISIT NOTES INDICATE THAT DRAINS WERE REMOVED ON THE PRIOR DAY AND THAT THE PATIENT STATED FEELING PRESSURE ON THE BREAST THE NEXT DAY. THE FOLLOWING DAY, A NURSE CALL NOTED THAT THE PATIENT REPORTED THE RIGHT BREAST FELT HARDER THAN THE OTHER. A CALL WAS THEN PLACED TO THE PLASTICS NURSE PRACTITIONER (NP) WITH THE PATIENT STATING THE RIGHT BREAST FELT ENGORGED. THE PATIENT SENT PICTURES, AND THE NP DETERMINED VISUALLY THERE WERE NO ISSUES AND TO CONTINUE TO MONITOR. FOUR DAYS LATER, THE PATIENT VISITED WITH PLASTICS AND MILD ERYTHEMA TO THE RIGHT BREAST WITH A SMALL PALPABLE FLUID COLLECTION WAS OBSERVED. FIFTEEN CCS OF SEROSANGUINOUS FLUID WERE REMOVED FROM THE RIGHT BREAST AND SENT FOR CULTURE. BACTRIM WAS PRESCRIBED PROPHYLACTICALLY. SURGERY FOR EXPANDER REPLACEMENT WAS SCHEDULED AS THE INVESTIGATOR STATED THAT SHE DIDN'T WANT THE SEROMA TO GET WORSE OR BECOME INFECTED. THE TISSUE EXPANDER REPLACEMENT SURGERY OCCURRED AS PLANNED AND THE PATIENT WAS EXPANDED TO THE SIZE SHE WANTED, ELIMINATING THE NEED FOR ANY MORE FILLS. ALL LABS WERE NEGATIVE FOR INFECTION." } ], "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": "" } ] }