{ "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": "2955842-2022-11455", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20220507", "manufacturer_address_2": "", "pma_pmn_number": "UNKNOWN", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign", "Literature" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "BR", "manufacturer_contact_area_code": "408", "date_added": "20220507", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "949574", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20220507", "brand_name": "DA VINCI", "generic_name": "DA VINCI SURGICAL SYSTEM", "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": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "N/A", "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": "R", "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": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250801", "health_professional": "", "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": "20220507", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Pneumonia", "Sepsis", "Pneumonia", "Sepsis" ] } ], "distributor_city": "", "date_report": "20200402", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "14325433", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20200402", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "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": "291193152", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AN ISI INTERNAL MEDICAL SAFETY OFFICER PROVIDED THE FOLLOWING AFTER REVIEWING THE CASE INFORMATION: BASED UPON THE INFORMATION PROVIDED IN THE JOURNAL BRASILEIRO DE PNEUMOLOGIA ARTICLE TITLED, ¿ROBOTIC THORACIC SURGERY FOR NON-SMALL CELL LUNG CANCER: INITIAL EXPERIENCE IN BRAZIL¿ (TERRA, R. M., BIBAS, B. J., ET AL., 2020), A PATIENT WHO UNDERWENT A DA VINCI-ASSISTED LOBECTOMY DEVELOPED PNEUMONIA, SEPSIS, AND MULTIPLE ORGAN FAILURE AND EXPIRED 12 DAYS AFTER THE LOBECTOMY. THE LEAD AUTHOR OF THE ARTICLE WAS CONTACTED REGARDING THE REPORTED MORTALITY. THE LEAD AUTHOR STATED THAT THERE WERE NO ALLEGATIONS OR CLAIMS THAT A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY MALFUNCTIONED DURING THE PROCEDURE. THE LEAD AUTHOR ALSO STATED THAT \"THE PROCEDURE-RELATED DEATH WAS ONE CASE IN WHICH THE PATIENT COURSED WITH PNEUMONIA AFTER THE PROCEDURE. NOTHING RELATED TO THE ACCESS ROUTE OR DA VINCI SYSTEM.\" PNEUMONIA IS CONSIDERED ONE OF THE MOST COMMON AND ONE OF THE MOST SERIOUS COMPLICATIONS AFTER LUNG RESECTION. ACCORDING TO THE FINDINGS IN THORACIC SURGERY ARTICLE TITLED, ¿LONG-TERM IMPACT OF DEVELOPING POSTOPERATIVE PULMONARY COMPLICATIONS AFTER LUNG SURGERY¿ (SEBASTIAN, L., AGOSTINI, P, ET. AL.) PATIENTS WHO DEVELOPED POSTOPERATIVE PNEUMONIA HAD A SIGNIFICANTLY HIGHER 30-DAY (9% VS 0.7%; P<0.001) AND A 90-DAY MORTALITY (17% VS 2.9%; P<0.001). PREVIOUS INVESTIGATIONS HAVE IDENTIFIED INDEPENDENT RISK FACTORS FOR DEVELOPING POSTOPERATIVE PNEUMONIA ARE AS FOLLOWS: SMOKING, ADVANCED AGE (AGE>75 YEARS OLD), REDUCED MOBILITY, ASA SCORE > OR = TO 3, CARDIOVASCULAR COMORBIDITY, COPD, AND BMI > OR = 30. BASED UPON THE INFORMATION CONTAINED WITHIN THE DESCRIPTION OF EVENTS, THE SURGEON OF RECORD INDICATED THAT THE PATIENT EXPIRED DUE TO COMPLICATIONS FROM PNEUMONIA AFTER A DA VINCI-ASSISTED LOBECTOMY. THE EXTENT TO WHICH THE DA VINCI SYSTEM, INSTRUMENTATION, AND/OR ACCESSORIES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT¿S PNEUMONIA IS UNKNOWN. DUE TO THE SITE, EVENT DATE, AND SYSTEM INFORMATION BEING UNKNOWN, SYSTEM/INSTRUMENT LOG REVIEWS CANNOT BE PERFORMED. NO IMAGES OR VIDEOS WERE SHARED FOR THE EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: ON POST-OPERATIVE DAY #12 FOLLOWING A DA VINCI-ASSISTED LOBECTOMY SURGICAL PROCEDURE, A PATIENT EXPIRED FROM THE DEVELOPMENT OF PNEUMONIA, SEPSIS, AND MULTIPLE ORGAN FAILURE. WHILE THERE WAS NO ALLEGATION OR CLAIM OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY MALFUNCTION AND AN AUTHOR CORRESPONDENCE STATEMENT INDICATING THAT ¿THE PROCEDURE-RELATED DEATH WAS ONE CASE IN WHICH THE PATIENT COURSED WITH PNEUMONIA AFTER THE PROCEDURE. NOTHING RELATED TO THE ACCESS ROUTE OR DAVINCI SYSTEM,\" INSUFFICIENT EVIDENCE IS PRESENT TO DEFINITIVELY RULE OUT THE POTENTIAL FOR THE DEVICE TO HAVE CAUSED OR CONTRIBUTED TO THE EVENT." }, { "mdr_text_key": "291193153", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ON 02-APR-2020, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A \"JORNAL BRASILEIRO DE PNEUMOLOGIA\" ARTICLE TITLED, ¿ROBOTIC THORACIC SURGERY FOR NON-SMALL CELL LUNG CANCER: INITIAL EXPERIENCE IN BRAZIL¿ (TERRA, R. M., BIBAS, B. J., ET AL., 2020). WITHIN THE JOURNAL ARTICLE, AN OPERATIVE COMPLICATION INVOLVING A DA VINCI SURGICAL PROCEDURE WAS NOTED. IT WAS NOTED THAT A ¿PROCEDURE-RELATED DEATH OCCURRED IN 1 PATIENT (0.5%), 12 DAYS AFTER A LOBECTOMY. THAT PATIENT HAD DEVELOPED PNEUMONIA, SEPSIS, AND MULTIPLE ORGAN FAILURE.¿ THE ARTICLE CORRESPONDENT WAS CONTACTED TO GATHER ADDITIONAL INFORMATION AND THE INFORMATION WAS RECEIVED: THE ARTICLE CORRESPONDENT STATED THAT THERE WERE NO ALLEGATIONS OR CLAIMS THAT A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY MALFUNCTIONED DURING THE PROCEDURE. THE ARTICLE CORRESPONDENT ALSO STATED THAT \"THE PROCEDURE-RELATED DEATH WAS ONE CASE IN WHICH THE PATIENT COURSED WITH PNEUMONIA AFTER THE PROCEDURE. NOTHING RELATED TO THE ACCESS ROUTE OR DA VINCI SYSTEM.\"" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }