{ "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": "HOSPITAL", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Death", "report_number": "2955842-2014-04607", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20140730", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20140623", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "Foreign", "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20140730", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "445285", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20140730", "brand_name": "DA VINCI SI SURGICAL SYSTEM", "generic_name": "ENDOSCOPIC INSTRUMENT CONTROL SYSTEM", "manufacturer_d_name": "INTUITIVE SURGICAL,INC.", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "SUNNYVALE", "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": "IS 3000 A6.0P8", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "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": [ "Insufficient Device Problem Information" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*;*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250814", "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": "20140730", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death", " O", " R" ], "patient_age": "75 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20140707", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3966024", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20140822", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "21739667", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL HAS NOT DETERMINED THE ROOT CAUSE OF THE BLEEDING OR THE PATIENT'S DEATH. THE DATE OF THE PATIENT'S DEATH IS UNKNOWN. THERE IS NO ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY. ISI HAS ATTEMPTED TO CONTACT THE SURGEONS TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6) 2014 AND NO SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE REPORTED SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT DIED AFTER UNDERGOING A DA VINCI PROCEDURE WHICH WAS CONVERTED TO OPEN PROCEDURE. HOWEVER, AT THIS TIME THE CAUSE OF THE PATIENT'S INTRA-OPERATIVE COMPLICATIONS AND SUBSEQUENT DEMISE IS UNKNOWN." }, { "mdr_text_key": "11994917", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(4) 2014, THE SURGEON PROVIDED, INTUITIVE SURGICAL, INC. (ISI) THE FOLLOWING INFORMATION: THE PATIENT HAD A COMPLICATION DURING LOBECTOMY WHICH WAS NOT UNEQUIVOCALLY RELATED TO THE ROBOT-ASSISTED NATURE OF THIS PROCEDURE. THE SURGEON MENTIONED THAT IT WAS A (B)(6) MALE PATIENT WHO HAD SIGNIFICANT CARDIAC COMORBIDITY. THE PATIENT UNDERWENT A RIGHT VIDEO ASSISTED THORACIC SURGERY (R-VATS) LOBECTOMY OF THE LEFT UPPER LOBE (LUL) DUE TO ADENOCARCINOMA. DURING THE PROCEDURE,BLEEDING FROM THE APICAL BRANCH OF THE PULMONARY ARTERY (PA) OCCURRED, WHICH WAS MOST LIKELY DUE TO TOO MUCH TRACTION ON THE LUL BRONCHUS. THE PATIENT UNFORTUNATELY DEVELOPED HYPOVOLEMIA DURING SEVERAL MINUTES WITH CEREBRAL HYPOXIA AS A RESULT. HE DIED ONE DAY AFTER SURGERY DUE TO THIS CEREBRAL COMPLICATION. AN AUTOPSY HAS NOT BEEN PERFORMED. NO FURTHER CLINICAL INFORMATION WAS PROVIDED REGARDING THIS CASE." }, { "mdr_text_key": "21492610", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT A PATIENT UNDERWENT A DA VINCI LOBECTOMY PROCEDURE AND THE CASE WAS CONVERTED TO OPEN DUE TO BLEEDING. AN INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) SPOKE TO THE SURGEON AND WAS INFORMED THAT THE PATIENT DID NOT TOLERATE THE PROCEDURE WELL AND DIED. NO FURTHER CLINICAL INFORMATION WAS PROVIDED ABOUT THE EVENT." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "08/25/2014;09/18/2014" } ] }