{ "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": "", "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": "2955842-2009-00217", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20090710", "manufacturer_address_2": "", "pma_pmn_number": "K081207", "date_of_event": "20090608", "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": "US", "manufacturer_contact_area_code": "", "date_added": "20090716", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20090710", "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": "US", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "IS2000 A5.1P7", "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": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "KS", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "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": "20090710", "sequence_number_treatment": [ "DA VINCI S SURGICAL SYSTEM INSTRUMENTS", " ACCESSORIES" ], "sequence_number_outcome": [ "Death" ], "patient_age": "43 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death" ] } ], "distributor_city": "", "date_report": "20090611", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "1413107", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20090611", "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": "16036917", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT POST A DA VINCI S LUNG BIOPSY SURGICAL PROCEDURE, THE PT EXPIRED. THE SITE STATED THAT THE PLANNED DA VINCI S PROCEDURE WAS SUCCESSFULLY COMPLETED, HOWEVER, THE PT WAS IN OVERALL POOR HEALTH." }, { "mdr_text_key": "16160774", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "IN 2009, THE SITE'S OPERATING ROOM MANAGER STATED THAT SHE BELIEVES THE DA VINCI S SYSTEM IN NO WAY CONTRIBUTED TO THE DEMISE OF THE PATIENT. THE HOSPITAL HAS CONTINUED TO USE THE DA VINCI S SURGICAL SYSTEM TO PERFORM SURGERY ON PTS. AS OF THE FOLLOWING MONTH, NO ADVERSE EVENTS HAVE BEEN EXPERIENCED WITH THE SITE'S SYSTEM. THE SAME DAY, THE SITE'S RISK MGR. STATED SHE IS UNABLE TO RELEASE THE PT'S PRE-EXISTING MEDICAL CONDITION INFORMATION NOR IS SHE ABLE TO PROVIDE THE OPERATING REPORT RELATED TO THIS EVENT. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE SITE RELATED TO THIS EVENT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. BASED ON THE INFORMATION PROVIDED BY THE SITE, IT WAS DETERMINED THAT THE DA VINCI S SURGICAL SYSTEM DID NOT MALFUNCTION IN A WAY THAT WOULD HAVE LED OR CONTRIBUTED TO THE PT'S DEATH." } ], "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": "" } ] }