{ "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": "Death", "report_number": "2955842-2026-05349", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20260222", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20260126", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "KS", "manufacturer_contact_area_code": "", "date_added": "20260223", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20240404", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "472016", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260222", "brand_name": "DA VINCI SP", "generic_name": "SURGEON SIDE CONSOLE", "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": "380940-45", "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": "00886874114735", "udi_public": "(01)00886874114735", "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": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20260430", "health_professional": "", "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": "20260222", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention", " D" ], "patient_age": "NA", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Great Vessel Perforation" ] } ], "distributor_city": "", "date_report": "20260222", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "24411015", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20260127", "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": "393625680", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "REVIEW OF THE INTRAOPERATIVE SYSTEM LOGS FOR THE DURATION OF THIS PROCEDURE SHOW THE SYSTEM FUNCTIONED NORMALLY AND THERE WERE NO INDICATIONS RELATING TO THIS EVENT. LOG REVIEW OF THE 5 SUBSEQUENT PROCEDURES FOUND THE SYSTEM FUNCTIONED NORMALLY; NO INTRAOPERATIVE EVENTS OR ISSUES WERE OBSERVED. THE FOLLOWING CONCOMITANT PRODUCTS WERE USED DURING THIS PROCEDURE: 0 DEGREE ENDOWRIST CAMERA, SP MARYLAND BIPOLAR FORCEPS, SP FENESTRATED BIPOLAR FORCEPS, MARYLAND BIPOLAR FORCEPS. A SITE HISTORY REVIEW FOUND NO COMPLAINTS WERE MADE FOR THE INSTRUMENTS USED DURING THIS PROCEDURE. A REVIEW OF THE EVENT PERFORMED BY AN INTUITIVE SURGICAL MEDICAL SAFETY OFFICER (MSO) CONCLUDED THAT THE PATIENT IN THIS REPORT DIED AS A RESULT OF AN INADVERTENT INJURY TO THE PULMONARY ARTERY USING A THIRD-PARTY DEVICE. BASED ON THE INFORMATION PROVIDED IN THE SUMMARY OF EVENTS, NO INTUITIVE SURGICAL PRODUCT OR INSTRUMENT CONTRIBUTED TO THIS EVENT. ." }, { "mdr_text_key": "393625681", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY PROCEDURE, AN INADVERTENT PERFORATION OF THE PULMONARY ARTERY OCCURRED WHILE USING A THIRD-PARTY LAPAROSCOPIC STAPLER INSTRUMENT, RESULTING IN SIGNIFICANT HEMORRHAGE AND THE PATIENT ULTIMATELY EXPIRED. THE EXACT VOLUME OF BLOOD LOSS IS UNKNOWN. THE SURGEON DOES NOT BELIEVE THAT THE DA VINCI SYSTEM, INSTRUMENTS, OR ACCESSORIES CAUSED OR CONTRIBUTED TO THE EVENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT THE CUSTOMER HAS INDICATED THAT THEY WILL NOT GRANT PERMISSION FOR FURTHER ACCESS TO THE EVENT INFORMATION." } ], "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": "" } ] }