{ "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": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "SANTA CLARA", "manufacturer_contact_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_contact_pcity": "40852321", "event_type": "Injury", "report_number": "2955842-2025-47083", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20251202", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20251106", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "JA", "manufacturer_contact_area_code": "408", "date_added": "20251202", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20240828", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1874931", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20251202", "brand_name": "DA VINCI SP", "generic_name": "VISION SYSTEM CART", "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": "380941-51", "catalog_number": "N/A", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20251121", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "00886874114742", "udi_public": "(01)00886874114742", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Output Problem", "Output Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "12/03/2025", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20260112", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "4085", "patient": [ { "patient_sequence_number": "1", "date_received": "20251202", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "63 YR", "patient_sex": "Male", "patient_weight": "65 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Tissue Injury", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20251222", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "23693753", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20251106", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "95051", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "INTUITIVE SURGICAL, INC", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "386511420", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE COULD NOT REPRODUCE THE REPORTED ISSUE AND COULD NOT VERIFY THE ERROR IN THE SYSTEM LOGS. THE ENERGY SHIELD MONITOR (ESM) WAS PROACTIVELY REPLACED. AN INTUITIVE SURGICAL, INC. (ISI) PRODUCT HAS BEEN RECEIVED FOR FAILURE ANALYSIS EVALUATION. HOWEVER, THE FAILURE ANALYSIS INVESTIGATION HAS NOT BEEN COMPLETED AT THE TIME OF THIS REPORT." }, { "mdr_text_key": "386511421", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE THAT THE ENERGY CORD LED ON THE ENERGY SHIELD MONITOR (ESM) TURNED YELLOW, AND THE MONOPOLAR ENERGY COULD NOT BE USED. REPLACING THE ENERGY CORDS AND RESTARTING BOTH THE ESM AND THE SYSTEM DID NOT RESOLVE THE ISSUE. DUE TO THIS, THE USER DECIDED TO CONVERT THE SINGLE PORT PROCEDURE TO LAPAROSCOPIC. THERE WERE NO REPORTS OF PATIENT INJURY." }, { "mdr_text_key": "388943122", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "388943123", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE ENERGYSHIELD MONITOR (ESM) ASSEMBLY WAS RECEIVED FOR FAILURE ANALYSIS. THE REPORTED ISSUE WAS NEITHER CONFIRMED NOR REPLICATED. UPON VISUAL INSPECTION NO ISSUES WERE FOUND. THE UNIT WAS INSTALLED ONTO A TEST SYSTEM AND FUNCTIONED AS EXPECTED. THE MONOPOLAR CABLE WAS PLUGGED IN MULTIPLE TIMES WITH NO ISSUES. ALL LEDS WERE SEEN ON AND FUNCTIONAL. THE UNIT WAS ALSO LEFT TO IDLE FOR ABOUT 2 HOURS HOWEVER NO FAULTS OR ERRORS WERE TRIGGERED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "12/22/2025" } ] }