{ "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": "I", "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": "2955842-2020-10226", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200325", "manufacturer_address_2": "", "pma_pmn_number": "", "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", "OTHER" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20200325", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "340632", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200325", "brand_name": "DA VINCI SURGICAL SYSTEM", "generic_name": "DAVINCI SYSTEM", "manufacturer_d_name": "INTUITIVE SURGICAL, INC", "manufacturer_d_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_d_address_2": "", "manufacturer_d_city": "SANTA CLARA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "95051", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95051", "device_operator": "HEALTH PROFESSIONAL", "model_number": "N/A", "catalog_number": "N/A", "lot_number": "N/A", "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": { "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", "Insufficient Device Problem Information" ], "reporter_state_code": "OH", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/17/2020", "mfr_report_type": "", "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": "20200325", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES", " DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Death" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Sepsis", "Death", "Sepsis" ] } ], "distributor_city": "", "date_report": "20180621", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "9880265", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20180621", "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": "314998073", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UPDATED INFORMATION CAN BE FOUND IN THE FOLLOWING FIELDS: G4, G7, H2, H10. CORRECTED INFORMATION CAN BE FOUND IN THE FOLLOWING FIELDS: D2, D4, AND H10. THE FIELDS IN SECTION D4 ARE UNKNOWN AS THE SPECIFIC SYSTEM THAT WAS USED AT THE TIME OF THE REPORTED EVENT IS NOT KNOWN. H4 SHOULD HAVE BEEN INCLUDED IN THE LIST OF BLANK MDR FIELDS IN H10 ON THE INITIAL MDR. SINCE THE SPECIFIC SYSTEM THAT WAS USED IS UNKNOWN, THE DATE OF MANUFACTURE COULD NOT BE OBTAINED." }, { "mdr_text_key": "314998074", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "184930084", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED THE CAUSE OF THE REPORTED DEATH IS UNKNOWN. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP MDR WILL BE SUBMITTED. ISI HAS MADE ADDITIONAL ATTEMPTS TO CONTACT THE SITE AND GATHER PATIENT INFORMATION. HOWEVER, THE SITE WAS EITHER UNWILLING TO PROVIDE ADDITIONAL INFORMATION OR AS OF THE DATE OF THIS REPORT, NO NEW INFORMATION HAS BEEN OBTAINED. NO SYSTEM LOGS AVAILABLE, SINCE THE PROCEDURE DATE IS UNKNOWN AND THE SYSTEM USED RELATED TO THE EVENT CANNOT BE DETERMINED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: IT WAS REPORTED THAT AFTER UNDERGOING A CYSTECTOMY PROCEDURE ON AN UNSPECIFIED DATE, THE PATIENT DEVELOPED POST-OPERATIVE SEPSIS AND ULTIMATELY EXPIRED. ALTHOUGH THE SURGEON STATED THAT THE DEATH WAS NOT CAUSED BY A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY, SINCE THE DATE OF THE SURGERY COULD NOT BE CONFIRMED, FURTHER EVALUATION OF THE SYSTEM OR INSTRUMENTS USED IN THE PROCEDURE COULD NOT BE PERFORMED. THIS REPORT HAS BEEN GENERATED IN RESPONSE TO FDA INSPECTIONAL OBSERVATIONS DATED 6-MAR-2020." }, { "mdr_text_key": "184930085", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT AFTER UNDERGOING A CYSTECTOMY PROCEDURE ON AN UNSPECIFIED DATE, THE PATIENT DEVELOPED POST-OPERATIVE SEPSIS AND ULTIMATELY EXPIRED. THE SURGEON STATED THAT THE DEATH WAS NOT CAUSED BY A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY. ON 22-JUN-2018, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES MANAGER (CSM) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION FROM THE SURGEON REGARDING THE REPORTED EVENT: THERE WAS NOTHING RELATED TO DA VINCI IN THIS SITUATION THAT NEEDED FOLLOW UP. NO ADDITIONAL INFORMATION REGARDING THE DATE OF THE PROCEDURE OR PATIENT INVOLVED WAS OBTAINED." } ], "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": "09/13/2020" } ] }