{ "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": "2955842-2012-00435", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20120914", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20120827", "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", "User facility" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20120917", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20120914", "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 A6.0P6", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "N", "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": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250805", "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": "20120914", "sequence_number_treatment": [ "DAVINCI SI SYSTEMS INSTRUMENT AND ACCESSORIES" ], "sequence_number_outcome": [ "Death" ], "patient_age": "50 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Pulmonary Embolism", "Death" ] } ], "distributor_city": "", "date_report": "20120904", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "2746211", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20120904", "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": "3111289", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT APPROXIMATELY 2 WEEKS POST A DA VINCI SI HYSTERECTOMY PROCEDURE, THE PATIENT DEVELOPED A PULMONARY EMBOLISM AND EXPIRED." }, { "mdr_text_key": "10182525", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(6) 2012, INTUITIVE SURGICAL CONTACTED THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE AND HE INDICATED THAT THE PATIENT WAS RELEASED FROM THE HOSPITAL 2 DAYS POST OP AND THAT ONE WEEK POST OP THE PATIENT RETURNED TO THE HOSPITAL IN GOOD CONDITION; HOWEVER, IT WAS DISCOVERED THAT THE PATIENT HAD A SMALL LESION OF THE BLADDER DIATHERMIC. THE SURGEON INDICATED THE PATIENT GOT A CAD AND HAD NO COMPLAINTS ANYMORE AND WAS READY TO BE DISCHARGED FROM THE HOSPITAL WHEN SHE DEVELOPED A MASSIVE PULMONARY EMBOLISM. THE SURGEON INDICATED THAT THEY TRIED TO RESUSCITATE THE PATIENT WITHOUT SUCCESS AND THE PATIENT EXPIRED ON (B)(6) 2012. THE SURGEON INDICATED THAT THERE WAS NO MALFUNCTION OF THE DA VINCI SI SYSTEM, INSTRUMENTS AND/OR ACCESSORIES DURING THE PLANNED SURGICAL PROCEDURE AND THAT THE PROCEDURE WAS NOT RELATED TO THE PULMONARY EMBOLISM THAT THE PATIENT DEVELOPED. NO OTHER INFORMATION WAS PROVIDED. IF ADDITIONAL INFORMATION IS PROVIDED A FOLLOW-UP MDR WILL BE SUBMITTED." } ], "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": "" } ] }