{ "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": "2955842-2013-05450", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131126", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20131022", "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": "20131126", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "614884", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131126", "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": "WI", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250810", "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": "20131126", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death", " L" ], "patient_age": "78", "patient_sex": "", "patient_weight": "88", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Stroke/CVA", "Death", "Loss of Vision" ] } ], "distributor_city": "", "date_report": "20131031", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3489457", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20131031", "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": "4003547", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI LOWER ANTERIOR RESECTION PROCEDURE PERFORMED ON (B)(6) 2013, THE SURGEON INDICATED THAT THE PATIENT EXPERIENCED A STROKE AND SUBSEQUENTLY PASSED AWAY ON AN UNSPECIFIED DATE. ACCORDING TO THE INITIAL REPORTER, THE SURGEON INFORMED HIM THAT THE PATIENT HAD MANY CO-MORBID CONDITIONS, WOKE UP BLIND, AND LATER PASSED AWAY. ON (B)(6) 2013, ISI CONTACTED THE RISK MANAGER (RM) AT THE SITE. THE RM REVIEWED THE PATIENT'S MEDICAL HISTORY AND NOTED THAT THE PATIENT HAD EXPERIENCED MULTIPLE STROKES IN THE PAST PRIOR TO UNDERGOING THE DA VINCI SURGICAL PROCEDURE ON (B)(6) 2013. THE PATIENT'S MEDICAL HISTORY INCLUDED PROSTATE CANCER, ABDOMINAL ANEURYSMS, AORTIC ANEURYSM, CORONARY ATHEROSCLEROSIS, HEART DISEASE, COLON CANCER, HYPERTENSION, DIASTOLIC DYSFUNCTION, AND CHRONIC TOBACCO USE. THE RM ALSO REVIEWED THE OPERATIVE REPORT AND DID NOT FIND ANY NOTATION THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. ACCORDING TO THE OPERATIVE REPORT, THERE WERE NO COMPLICATIONS AND THE PATIENT TOLERATED THE PROCEDURE WELL. BASED ON THE PATIENT'S MEDICAL RECORDS, THE PATIENT WOKE UP POST-OPERATIVELY WITH COMPLAINTS OF VISION LOSS. CARDIOLOGY CONCLUDED THAT AN OCCLUSION OF THE PATIENT'S POSTERIOR CEREBRAL ARTERY WAS A POSSIBLE CAUSE OF THE PATIENT'S REPORTED LOSS OF VISION. MULTIPLE RADIOLOGICAL TESTS WERE PERFORMED POST-OPERATIVELY AND AN MRI CONFIRMED THAT THE PATIENT HAD EXPERIENCED AN ACUTE ISCHEMIC STROKE. A FEW DAYS AFTER COMPLETION OF THE SURGICAL PROCEDURE, THE PATIENT EXPERIENCED A SUBSEQUENT HEMORRHAGIC STROKE. THE RM STATED THAT THE PATIENT'S FAMILY WAS CONSULTED AND THE DECISION WAS MADE BY THE FAMILY AND SURGEON TO EXTUBATE THE PATIENT ON (B)(6) 2013. THE PATIENT PASSED AWAY THE FOLLOWING DAY ON (B)(6) 2013. ACCORDING TO THE RM, AN AUTOPSY HAD NOT BEEN COMPLETED YET." }, { "mdr_text_key": "11254795", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE FOR THE OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT AND HIS SUBSEQUENT DEMISE. THERE WERE NO REPORTS THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED DURING THE DA VINCI SURGICAL PROCEDURE. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6) 2013. NO SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: ACCORDING TO THE SURGEON, THE PATIENT EXPERIENCED A STROKE WHILE UNDERGOING A DA VINCI SURGICAL PROCEDURE AND SUBSEQUENTLY PASSED AWAY. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S STROKE AND DEMISE ARE 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": "" } ] }