{ "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": "2955842-2014-03344", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20140530", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20140210", "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": [ "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20140530", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "318458", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20140530", "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 A6.0P8", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "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": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "AZ", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250819", "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": "20140530", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "88 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Tissue Damage" ] } ], "distributor_city": "", "date_report": "20140502", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3841031", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20140502", "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": "4407935", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT POST A DA VINCI HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY AND PARA AORTIC NODE DISSECTION PROCEDURE PERFORMED ON (B)(6) 2014 THE PATIENT UNDERWENT A SECOND SURGICAL PROCEDURE DUE TO INFARCTION OF THE RIGHT COLON. THE DATE OF THE PATIENT'S DEMISE WAS NOT REPORTED AND IT IS THE SURGEON'S BELIEF THAT THE PATIENT'S DEMISE WAS UNRELATED TO THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES. ON (B)(6) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE. ACCORDING TO THE SURGEON THERE WAS NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES THAT CAUSED OR CONTRIBUTED TO THE PATIENT'S DEMISE. THE PATIENT HAD UTERINE CANCER AND BOWEL ISCHEMIA. THE SURGEON INDICATED THAT THE PATIENT'S DEMISE WAS UNRELATED TO THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES, BUT WAS CAUSED BY THE PATIENT'S BOWEL ISCHEMIA. DUE TO HIPPA REGULATIONS, THE SURGEON DECLINED TO PROVIDE ANY OTHER INFORMATION REGARDING THE PATIENT." }, { "mdr_text_key": "11815026", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, IT HAS BEEN DETERMINED THAT THE PATIENT'S DEMISE WAS UNRELATED TO THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES; BUT OCCURRED AS A RESULT OF THE PATIENT'S BOWEL ISCHEMIA. REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE FOUND THAT NO SYSTEM ERRORS WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE INJURY SUSTAINED BY THE PATIENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: POST A DA VINCI HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY AND PARA AORTIC NODE DISSECTION PROCEDURE THE PATIENT HAD TO UNDERGO A SECOND SURGICAL PROCEDURE DUE TO BOWEL ISCHEMIA. THE PATIENT SUBSEQUENTLY DIED. BASED ON THE INFORMATION PROVIDED BY THE SURGEON, THE PATIENT'S BOWEL ISCHEMIA AND DEMISE WERE UNRELATED TO THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES." } ], "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": "" } ] }