{ "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": "2955842-2024-17057", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20240723", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20231130", "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": "20240723", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1004389", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240723", "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", "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": "MO", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250807", "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": "20240723", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "43 YR", "patient_sex": "Female", "patient_weight": "44 KG", "patient_ethnicity": "Non Hispanic", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Low Blood Pressure/ Hypotension", "Breast Mass", "Hemorrhage/Blood Loss/Bleeding", "Low Blood Pressure/ Hypotension", "Breast Mass" ] } ], "distributor_city": "", "date_report": "20240626", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "19806974", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20240626", "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": "347490330", "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 REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE SHOWED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT." }, { "mdr_text_key": "347490331", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED BILATERAL NIPPLE SPARING MASTECTOMY (NSM) PROCEDURE FOR THE PATIENT'S RIGHT BREAST CANCER AND LEFT BREAST PROPHYLACTICALLY, THE PATIENT EXPERIENCED POST-OPERATIVE HYPOTENSION PRIOR TO DISCHARGE THAT REQUIRED A BLOOD TRANSFUSION. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITHOUT ANY DEVICE MALFUNCTIONS REPORTED. THE INTRA-OPERATIVE BLOOD LOSS WAS REPORTED AS 170ML BUT WAS NOT AN UNEXPECTED VOLUME FOR THE TYPE OF PROCEDURE. NO MEDICAL OR SURGICAL INTERVENTION WAS RENDERED TO STOP THE BLEEDING. ON THE NIGHT OF THE PROCEDURE, THE PATIENT WAS NOTED TO BE HYPOTENSIVE. ON POST-OPERATIVE DAY #2, LAB RESULTS INDICATED A HEMOGLOBIN LEVEL OF 6.6. ONE UNIT OF PACKED RED BLOOD CELLS (PRBC) WAS TRANSFUSED THE NEXT DAY AND THE HYPOTENSION WAS RESOLVED WITH A HEMOGLOBIN LEVEL OF 8.8. THE PATIENT WAS DISCHARGED ON POST-OPERATIVE DAY #3. THE SURGEON BELIEVED THE CAUSE OF THE HYPOTENSION WAS DUE TO INTRA-OPERATIVE BLOOD LOSS AND HEMODILUTION. THREE MONTHS LATER, THE PATIENT WAS FOUND TO HAVE A RIGHT AXILLARY MASS. AN EXCISION OF THE MASS AND A REVISION OF THE BILATERAL BREAST RECONSTRUCTION WAS PERFORMED ON (B)(6) 2024. THE CAUSE OF THE MASS IS UNKNOWN AT THIS TIME." } ], "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": "" } ] }