{ "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": "2955842-2013-01749", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130519", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20130417", "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": [ "Health Professional", "User facility" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20130520", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "221089", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130519", "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": "", "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": "MO", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250817", "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": "20130519", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Death" ], "patient_age": "55 YR", "patient_sex": "", "patient_weight": "116", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Perforation of Vessels", "Great Vessel Perforation" ] } ], "distributor_city": "", "date_report": "20130418", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3119000", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130418", "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": "16380785", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(4) 2013, INTUITIVE SURGICAL, INC. (ISI) RECEIVED ADDITIONAL INFORMATION FROM THE INITIAL REPORTER OF THIS EVENT. THE INITIAL REPORTER INDICATED THAT THE PATIENT'S INJURIES WERE DISCOVERED DURING THE SURGICAL PROCEDURE AND THAT REPAIR OF THE AFFECTED VESSELS WERE NOT REPAIRED AS THE PATIENT EXPIRED. INTUITIVE SURGICAL HAS CONTACTED THE SITE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT. AS OF THE DATE OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE SITE. ON (B)(4) 2013, ISI CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR). THE CSR INDICATED THAT HE SPOKE TO THE INITIAL REPORTER OF THIS REPORT. THE CSR INDICATED THAT HE WAS TOLD BY THE INITIAL REPORTER THAT THE PATIENT'S RENAL ARTERY WAS DAMAGED DURING THE APPLICATION OF STAPLES. THE CSR WAS ALSO TOLD BY THE INITIAL REPORTER THAT THE SURGEON WAS USING AN ENDOWRIST GRASPER INSTRUMENT TO GRASP THE PATIENT'S AORTA AND THE CAMERA HAD BEEN REMOVED. REPORTEDLY, WHEN THE SURGEON RELEASED THE GRASPER INSTRUMENT FROM THE SURGEON SIDE CONSOLE, AND WITHOUT DIRECT VISUALIZATION OF THE SURGICAL SITE, DAMAGE TO THE PATIENT'S AORTA OCCURRED. THE CSR INDICATED THAT THE INITIAL REPORTER WAS UNABLE TO PROVIDE ANY OTHER DETAILS CONCERNING THE EVENTS AS THEY OCCURRED. A REVIEW OF THE SITE'S SYSTEM LOGS FOUND NO SYSTEM ERRORS OCCURRED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE LIMITED INFORMATION PROVIDED, IT IS UNKNOWN WHAT CAUSED THE PATIENT'S DEMISE." }, { "mdr_text_key": "16435721", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI SI NEPHRECTOMY PROCEDURE, THE PATIENT'S RENAL ARTERY, AORTA AND VENA CAVA WERE PUNCTURED AND THE PATIENT SUBSEQUENTLY EXPIRED. REPORTEDLY, THERE WAS NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM." } ], "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": "" } ] }