{ "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": "2955842-2008-00160", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20080326", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20080220", "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": [ "User facility" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20080401", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20080326", "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 A5.1P2", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "*", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "registration_number": [ "2955842" ], "fei_number": [ "3008615487" ], "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Replace", "Unknown (for use when the device problem is not known)" ], "reporter_state_code": "FL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "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": "20080326", "sequence_number_treatment": [ "DA VINCI S SURGICAL SYSTEM INSTRUMENTS", " ACCESSORIES" ], "sequence_number_outcome": [ "Death" ], "patient_age": "84 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Hemorrhage/Blood Loss/Bleeding", "Cardiogenic Shock", "Transfusion of blood products", "Low Cardiac Output" ] } ], "distributor_city": "", "date_report": "20080321", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "1020383", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20080305", "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": "15561508", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON MARCH 5, 2008, INTUITIVE SURGICAL WAS NOTIFIED PER A CUSTOMER PROVIDED LETTER: \"THIS GENTLEMEN WAS DIAGNOSED WITH SEVERE MITRAL REGURGITATION. HE WAS ORIGINALLY EVALUATED FOR POSSIBLE CANDIDACY FOR TRANSMITRAL PERCUTANEOUS REPAIR. HE WAS TURNED DOWN DUE TO MITRAL ANATOMY. THE PT WAS REFERRED HERE FOR POSSIBLE ROBOTIC INTERVENTION AND AGREED TO PROCEED WITH THE SURGERY. INCIDENTLY, THE PT HAD A TEE WHICH REVEALED A VERY CALCIFIED VALVE WITH SEVERE MITRAL VALVE REGURGITATION AND FAIR OVERALL EJECTION FRACTION ABOUT 50%. THE PROCEDURE WAS PERFORMED ROBOTICALLY, INITIALLY WITH FAILURE OF THE MITRAL VALVE REPAIR NECESSITATING FURTHER BYPASS AND MITRAL RING ANNULOPLASTY, WHICH ALSO FAILED-NECESSITATING MITRAL VALVE REPLACEMENT. MULTIPLE TRANSFUSIONS WERE GIVEN INTRAOPERATIVELY (PRBC, 16 UNITS, PLASMA-14 UNITS, CRYO-40 UNITS, PLATELETS-90 UNITS). THE PT WAS IN THE OPERATING ROOM FROM 8:30AM-12 MIDNIGHT. ULTIMATELY, THE PT DEVELOPED LOW CARDIAC OUTPUT, CARDIOGENIC SHOCK AND UNCONTROLLABLE BLEEDING DIATHESIS. DEMISE AT 16:35.\"" }, { "mdr_text_key": "15845107", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON MARCH 5, 2008, INTUITIVE SURGICAL SPOKE TO THE VICE PRESIDENT OF QUALITY MANAGEMENT AT THE ACCOUNT REGARDING THE INCIDENT. THE VICE PRESIDENT OF QUALITY MANAGEMENT PROVIDED A LETTER MARCH 12, 2008, STATING THAT THE PATIENT'S PREVIOUS MEDICAL HISTORY AND ANATOMY CONTRIBUTED TO THE PT'S DEATH. NO MALFUNCTION OF THE SYSTEM WAS ALLEGED BY THE HOSPITAL. THE HOSPITAL HAS CONTINUED TO USE THE DA VINCI S SYSTEM TO PERFORM SURGERY ON PATIENTS." } ], "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": "" } ] }