{ "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": "I", "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": "2955842-2017-00188", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "", "date_received": "20170331", "manufacturer_address_2": "", "pma_pmn_number": "K131861", "date_of_event": "20170310", "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": [ "OTHER" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20170331", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "233081", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20170331", "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": "IS3000 A60P9B", "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", "Insufficient Device Problem Information" ], "reporter_state_code": "FL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "10/02/2017", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250806", "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": "20170331", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Blood Loss", "Death", "Blood Loss" ] } ], "distributor_city": "", "date_report": "20170314", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "6450199", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20170314", "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": "71406751", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE INTRA-OPERATIVE COMPLICATION EXPERIENCED BY THE PATIENT AND THE PATIENT'S SUBSEQUENT DEMISE. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP MDR WILL BE SUBMITTED TO THE FDA. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2017. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE, THE INITIAL REPORTER INDICATED THAT THE PATIENT EXPERIENCED BLEEDING AND SUBSEQUENTLY EXPIRED. HOWEVER, AT THIS TIME, THE ROOT CAUSES OF THE PATIENT'S INTRA-OPERATIVE COMPLICATION AND DEATH ARE UNKNOWN." }, { "mdr_text_key": "71406752", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY PROCEDURE, THE PATIENT EXPERIENCED BLEEDING AND SUBSEQUENTLY EXPIRED. THERE WERE NO REPORTS OF ANY ISSUES WITH THE DA VINCI SURGICAL SYSTEM DURING THE SURGICAL PROCEDURE. ON 03/24/2017, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE CSR WAS PRESENT DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE WHICH WAS NOT RECORDED ON VIDEO. DURING THE SURGICAL PROCEDURE, THE PATIENT EXPERIENCED BLEEDING FROM AN UNSPECIFIED VESSEL. AS A RESULT OF THE BLEEDING, THE SURGEON MADE THE DECISION TO CONVERT TO OPEN SURGERY. AT THAT TIME THE CSR REPORTEDLY LEFT THE OR. AFTER THE EVENT OCCURRED, THE CSR SPOKE TO THE SURGEON. ACCORDING TO THE CSR, THERE WAS NO ALLEGATION FROM THE SURGEON THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE OR CAUSED/CONTRIBUTED TO THE PATIENT'S INTRA-OPERATIVE BLEEDING AND SUBSEQUENT DEATH. THE PATIENT REPORTEDLY EXPIRED ON THE OR TABLE." }, { "mdr_text_key": "105945353", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON OCTOBER 2, 2017, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM THE SITE'S RISK MANAGEMENT DEPARTMENT: NO MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THE PULMONARY ARTERY WAS FOUND TO BE BLEEDING INTRA-OPERATIVELY. HOWEVER, THE CAUSE OF THE PULMONARY ARTERY RUPTURE/TEAR IS UNKNOWN. IN ORDER TO ADEQUATELY CONTROL THE INTRA-OPERATIVE BLEEDING AND REPAIR THE VESSEL, THE SURGEON MADE THE DECISION TO CONVERT THE DA VINCI-ASSISTED PULMONARY LOBECTOMY PROCEDURE TO OPEN SURGERY. THE PLANNED SURGICAL PROCEDURE WAS NOT COMPLETED VIA OPEN SURGERY SINCE THE PATIENT EXPIRED ON THE OR TABLE. AN AUTOPSY WAS NOT PERFORMED. THE SITE BELIEVES THE PATIENT EXPIRED AS A RESULT OF AN INTRA-OPERATIVE HEMORRHAGE AND CARDIAC FAILURE. BASED ON THE CURRENT INFORMATION PROVIDED, THIS COMPLAINT WILL REMAIN REPORTABLE DUE TO THE FOLLOWING CONCLUSION: DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE, THE INITIAL REPORTER INDICATED THAT THE PATIENT EXPERIENCED BLEEDING AND SUBSEQUENTLY EXPIRED. HOWEVER, ALTHOUGH THERE IS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED, THE ROOT CAUSE OF THE PATIENT'S INTRA-OPERATIVE COMPLICATION IS UNKNOWN." } ], "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": "10/26/2017" } ] }