{ "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": "2955842-2010-00265", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20100617", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20100513", "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": "20100713", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20100617", "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 A6.0P3", "catalog_number": "SH0066", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "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": "LA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250729", "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": "20100617", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS, ACCESSORIES, ESU" ], "sequence_number_outcome": [ "Death" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Myocardial Infarction" ] } ], "distributor_city": "", "date_report": "20100518", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "1727307", "removal_correction_number": "", "number_devices_in_event": "", "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": "8619848", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B) (6) 2010, THE CONSOLE SURGEON PERFORMING THE PROCEDURE ADVISED THAT THE SYSTEM PERFORMED AS INTENDED WITH NO ISSUES AND THAT THE PATIENT'S DEATH WAS NOT RELATED IN ANY WAY TO THE DA VINCI SI SURGICAL SYSTEM. THE SURGEON WENT ON TO STATE THAT THE PATIENT HAD A KNOWN PRE-EXISTING CONDITION THAT WAS DIRECTLY RELATED TO THIS EVENT; HOWEVER, THE EXACT CONDITION WAS NOT DISCLOSED TO ISI. HE ALSO MENTIONED THE PATIENT HAD SUFFERED A HEART ATTACK DURING A PREVIOUS SURGICAL PROCEDURE PERFORMED SEVERAL YEARS AGO AND THE RISKS FOR THIS COLON RESECTION WERE KNOWN IN ADVANCE." }, { "mdr_text_key": "1408048", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT AFTER THE ROBOTIC PORTION OF A COLON RESECTION WAS SUCCESSFULLY PERFORMED, THE PATIENT SUFFERED A HEART ATTACK WHILE THE SURGEONS WERE CLOSING THE PATIENT USING STANDARD MEDICAL PROCEDURE. THE PATIENT WAS UNABLE TO BE RESUSCITATED AND EXPIRED ON THE TABLE." }, { "mdr_text_key": "20311043", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE CUSTOMER CONTACT REPORTED THE DEVICE DID NOT DELIVER A DOSE WHEN THE PT PENDANT WAS PRESSED. THE PUMP WAS RETURNED TO THE BIOMEDICAL DEPT FROM THE INPATIENT SURGERY UNIT WITH AN UNSIGNED NOTE THAT STATED, \"PT CABLE NOT WORKING.\" NO SPECIFIC PT INFO, PUMP PROGRAMMING, OR EVENT DETAILS WERE PROVIDED. DURING TESTING AT THE USER FACILITY, THE DEVICE DID NOT DELIVER A DOSE WHEN THE PT PENDANT WAS PRESSED. THE CUSTOMER CONTACT REPORTED THAT WHEN THE DEVICE WAS RETESTED USING A KNOWN GOOD PT PENDANT, THE DEVICE DELIVERED A DOSE WHEN THE PT PENDANT WAS PRESSED. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE PUMP WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED." }, { "mdr_text_key": "20402441", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "PRODUCT CODE HAS BEEN REMOVED PER FDA REQUEST." } ], "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": "07/13/2010" } ] }