{ "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": "2955842-2025-23027", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20250612", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20250519", "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": "20250612", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20200429", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1989162", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250612", "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": "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": "WA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250822", "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": "20250612", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization" ], "patient_age": "55 YR", "patient_sex": "Female", "patient_weight": "57 KG", "patient_ethnicity": "Non Hispanic", "patient_race": "White", "patient_problems": [ "Pneumothorax", "Pneumothorax" ] } ], "distributor_city": "", "date_report": "20250520", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "22197385", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250520", "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": "372298804", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A PATIENT WHO WAS ENROLLED IN A STUDY UNDERWENT A DA VINCI ASSISTED NIPPLE SPARING MASTECTOMY PROCEDURE. DURING SURGERY, THE PATIENT EXHIBITED CREPITUS IN THE ARMS ALONG WITH FACIAL AND NECK SWELLING; END-TIDAL CO2 AND ALL VITAL SIGNS REMAINED STABLE. INSUFFLATION PRESSURE, WHICH HAD BRIEFLY BEEN INCREASED FROM 10 MMHG TO 12 MMHG TO IMPROVE WORKING SPACE, WAS REDUCED BACK TO 10 MMHG, AND THE PROCEDURE WAS COMPLETED ROBOTICALLY WITHOUT ANY COMPROMISE TO THE PATIENT¿S HEMODYNAMIC STATUS. THE POST-PROCEDURE CHEST X-RAY NOTED A SMALL TO MODERATE RIGHT PNEUMOTHORAX. THE NEXT DAY, REPEAT CHEST X-RAY SHOWED A MODERATE SIZED RIGHT PNEUMOTHORAX, PNEUMOMEDIASTINUM, AND PNEUMOPERITONEUM IN THE SETTING OF EXTENSIVE SUBCUTANEOUS EMPHYSEMA. THE PATIENT DENIED DYSPNEA AND REMAINED HEMODYNAMICALLY STABLE WITH NORMAL OXYGEN SATURATION ON ROOM AIR. NO CHEST TUBE WAS PLACED AND THE PATIENT REMAINED HOSPITALIZED FOR OBSERVATION ONLY. A CHEST CT SCAN AND SERIAL CHEST X-RAYS SHOWED STABILITY OF THE SIZE OF THE PNEUMOTHORAX, PNEUMOMEDIASTINUM AND PNEUMOPERITONEUM. THE PATIENT REMAINED STABLE ON ROOM AIR WITH NO DYSPNEA AND WAS DISCHARGED HOME THREE DAYS POST-PROCEDURE." }, { "mdr_text_key": "372298805", "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. HEIGHT - 159 CM., BODY MASS INDEX (BMI) - 22.6 KG/M2." } ], "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": "" } ] }