{ "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": "2955842-2010-00074", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20100228", "manufacturer_address_2": "", "pma_pmn_number": "K081207", "date_of_event": "20070813", "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": "20100228", "brand_name": "DA VINCI S 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": "IS2000", "catalog_number": "", "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": [ "Insufficient Device Problem Information" ], "reporter_state_code": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250806", "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": "20100228", "sequence_number_treatment": [ "DVS SYSTEM INSTRUMENTS & ACCESSORIES" ], "sequence_number_outcome": [ "Death" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death" ] } ], "distributor_city": "", "date_report": "20070814", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "1617093", "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": "1370790", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED IN (B)(4) THAT THE SIDE RAIL WAS DAMAGED ON WELDING." }, { "mdr_text_key": "1283492", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A PROCTORED DA VINCI S PROSTATECTOMY PROCEDURE, PERFORMED ON (B) (6) 2007, THE CASE WASN'T PROGRESSING. THE ISI REPRESENTATIVE IN ATTENDANCE DURING THE CASE ASKED THE HOSPITAL'S CHAIR OF UROLOGY TO COME TO THE OR AND MAKE A DECISION ON THE PROCEDURE. IT WAS DECIDED TO CONVERT THE CASE TO TRADITIONAL OPEN SURGICAL TECHNIQUES. THE NEXT DAY, THE ISI REPRESENTATIVE WAS CONTACTED BY THE HOSPITAL'S CHIEF OF UROLOGY AND NOTIFIED THAT THE PATIENT HAD PASSED. THE ISI REPRESENTATIVE IMMEDIATELY PROVIDED THIS INFORMATION TO HER DIRECT MANAGER AT THE TIME; HOWEVER, IT APPEARS THAT THE ISI REPRESENTATIVE'S DIRECT MANAGER DID NOT INTERNALLY ESCALATE THE EVENT INFORMATION VIA THE APPROPRIATE CHANNELS. THE ISI REPRESENTATIVE'S DIRECT MANAGER DURING THE TIME OF THE EVENT IS NO LONGER AN ISI EMPLOYEE, THEREFORE, IT CANNOT BE DETERMINED WHY THE INFORMATION WAS NOT ESCALATED APPROPRIATELY." }, { "mdr_text_key": "8562051", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "PRODUCT CODE HAS BEEN REMOVED PER FDA REQUEST." }, { "mdr_text_key": "8455166", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE FOLLOWING INFORMATION WAS REQUESTED FROM THE PROCTORING SURGEON: PATIENT'S MEDICAL HISTORY, COPY OF OPERATIVE REPORT, AND PATIENT AUTOPSY REPORT. ON FEBRUARY 17, 2010, THE PROTORING SURGEON'S REPRESENTATIVE INDICATED THAT THE INFORMATION WILL BE FORWARDED ONCE THE RECORDS ARE OBTAINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED." } ], "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" } ] }