{ "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": "2955842-2010-00360", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20100811", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20100703", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "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": "20100813", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20100811", "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": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "IS3000 A6.0P4", "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": "20250728", "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": "20100811", "sequence_number_treatment": [ "DA VINCI SI SYS INSTRUMENTS, ACCESSORIES AND ESU" ], "sequence_number_outcome": [ "Death" ], "patient_age": "60 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20100712", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "1795608", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20100712", "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": "8794357", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE HOSPITAL WAS CONTACTED TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, DESPITE SEVERAL ATTEMPTS THE SITE HAS DECIDED TO NOT PROVIDE ANY INFORMATION RELATED TO THIS EVENT. ON (B)(6) 2010, AN ISI CLINICAL SALES REPRESENTATIVE CONTACTED DR. (B)(6), THE OPERATING SURGEON, TO OBTAIN ADDITIONAL INFORMATION HOWEVER THE SURGEON DID NOT RESPOND. ON AUGUST 10, 2010, AN ISI CLINICAL SALES REPRESENTATIVE STATED SHE HAD LEFT SEVERAL MESSAGES WITH DR. (B)(6) HOWEVER NO RESPONSE HAD BEEN RECEIVED. ON AUGUST 10, 2010, AN ISI CLINICAL SALES MANAGER STATED IN A CONVERSATION HE HAD WITH DR. (B)(6) REGARDING THIS EVENT, DR. (B)(6) STATED THAT THE PATIENT HAD MANY PRE-EXISTING CONTRIBUTING HEALTH ISSUES BUT DID NOT WISH TO PROVIDE FURTHER DETAILS. NO MALFUNCTIONS OF THE DA VINCI SI SURGICAL SYSTEM WERE REPORTED TO HAVE OCCURRED DURING THE PROCEDURE AND THE HOSPITAL HAS CONTINUED TO USE THE SYSTEM TO PERFORM SURGERY ON PATIENTS. AS OF (B)(6) 2010, NO ADVERSE EVENTS HAVE BEEN EXPERIENCED WITH THE SITE'S SYSTEM." }, { "mdr_text_key": "1534742", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT APPROXIMATELY 1 TO 2 HOURS DURING A DA VINCI SI COLECTOMY / ABDOMINOPERINEAL RESECTION PROCEDURE, THE PATIENT BEGAN TO ABNORMALLY BLEED. THE SURGEON DECIDED TO CONVERT THE PROCEDURE TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO COMPLETE THE PLANNED SURGERY. NO PATIENT HARM WAS REPORTED. TWO DAYS POST THE DA VINCI SI PROCEDURE, THE PATIENT EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED." } ], "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": "" } ] }