{ "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": "2955842-2009-00110", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20090325", "manufacturer_address_2": "", "pma_pmn_number": "K081207", "date_of_event": "20081216", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "NURSE", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "Other" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20090406", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20090325", "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": [ "Unknown (for use when the device problem is not known)" ], "reporter_state_code": "", "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": "20090325", "sequence_number_treatment": [ "ACCESSORIES.", " DA VINCI S SURGICAL SYSTEM INSTRUMENTS AND" ], "sequence_number_outcome": [ "Death" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Cardiac Arrest", "Death", "Surgical procedure" ] } ], "distributor_city": "", "date_report": "20090223", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "1354232", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20090223", "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": "15659871", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ADDITIONAL INFORMATION REGARDING THE EVENT WAS PROVIDED TO ISI BY THE ATTENDING SURGEON'S OFFICE MANAGER. REP INDICATED THAT NO PT DEATH OCCURRED IN 2009. THE PT DEATH THEY HAVE ON RECORD ACTUALLY OCCURRED IN 2008, AND THE SURGICAL PROCEDURE USING THE DA VINCI S SURGICAL SYSTEM WAS PERFORMED FIVE DAYS PRIOR. REP MENTIONED THAT FORTY MINUTES INTO THE SURGICAL PROCEDURE THE PT'S BLOOD PRESSURE DROPPED AND THE PT WENT INTO CARDIAC ARREST. AT THAT POINT, THE PROCEDURE WAS TERMINATED. THE SURGICAL STAFF WAS ABLE TO REGAIN VITAL SIGNS, HOWEVER, THE PT HAD TO BE PUT ON LIFE SUPPORT. THE PT REMAINED IN THE ICU ON LIFE SUPPORT UNTIL HER HUSBAND DECIDED TO TAKE HER OFF. THE PT'S OFFICIAL DATE OF DEATH IS FIVE DAYS AFTER, AND THE PT'S FAMILY OPTED NOT TO HAVE AN AUTOPSY PERFORMED. REP ALSO INDICATED THAT THE ATTENDING SURGEON BELIEVES THE SYSTEM IN NO WAY CONTRIBUTED TO THE DEMISE OF THE PT. THE HOSPITAL HAS CONTINUED TO USE THE DA VINCI S SURGICAL SYSTEM TO PERFORM SURGERY ON PATIENTS. AS OF 2008, NO ADVERSE EVENTS HAVE BEEN EXPERIENCED WITH THE SITE'S SYSTEM. AS OF 2008, NO SIMILAR INSTANCES OF THIS EVENT HAVE BEEN REPORTED TO ISI. BASED ON THE INFORMATION PROVIDED BY THE SITE AND SURGEON, 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." }, { "mdr_text_key": "15448814", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IN 2009, INTUITIVE SURGICAL WAS FORWARDED VOLUNTARY REPORT BY THE FDA FOR A PT DEATH AT HOSPITAL. THE REPORT DETAILS ARE PROVIDED BELOW: CDRH MAUDE EVENT REPORT 2009. REPORT OUTCOME ATTRIBUTED TO EVENT: DEATH. DATE RECEIVED: 2009. EVENT DATE: 2009. EVENT DESCRIPTION THE FOLLOWING MONTH: HEALTHY FEMALE FOR OVARIAN CYSTECTOMY USING THE DAVINCI ROBOT. PT SUFFERED FATAL CARDIAC ARREST IN THE MIDDLE OF THE PROCEDURE. HISTORY OF HTN, BUT OTHER WISE HEALTHY. NO AUTOPSY DONE. DEVICE INFORMATION: BRAND: DAVINCI ROBOT. DEVICE OPERATOR: HEALTH PROFESSIONAL. DEVICE AVAILABLE FOR EVALUATION: Y. EXPIRATION DATE: IS REPORTER A HEALTH PROFESSIONAL?: Y." } ], "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": "" } ] }