{ "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": "2955842-2025-31860", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20250728", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20250703", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "NURSE", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20250728", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20190924", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2716727", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250728", "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": "380941-34", "catalog_number": "N/A", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20250716", "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": [ "Visual Prompts will not Clear", "Visual Prompts will not Clear" ], "reporter_state_code": "MI", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/11/2025", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20251021", "health_professional": "Y", "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": "20250728", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Tissue Injury", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20250703", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "22633720", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250703", "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": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "383083390", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE ENERGY SHIELD MONITOR (ESM) WAS RECEIVED AND FAILURE ANALYSIS. IN THE SYSTEM LOGS, THE SHIELD CURRENT CIRCUIT ERROR WAS SEEN CONFIRMING THE FAULT OCCURRED IN THE FIELD. DURING VISUAL INSPECTION, NO ISSUES WERE SEEN THAT WOULD BE RELATED TO THE REPORTED EVENT. THE UNIT WAS INSTALLED ONTO A GOLDEN SYSTEM WHERE THE COMPONENT HAD FUNCTIONED AS DESIGNED. ALL CONNECTIONS WERE TESTED AND VERIFIED TO BE FUNCTIONING PROPERLY. CAUTERY WAS ALSO TESTED, AND NO FAULTS OR ERRORS WERE TRIGGERED. A REVIEW OF THE SYSTEM LOGS REVEALED THE FOLLOWING POSSIBLE RELATED SYSTEM ERRORS: CAUTERY SHIELD MONITOR DETECTED THE SHIELD CURRENT MONITORING CIRCUIT WAS NOT WORKING. MOST LIKELY BECAUSE THE SHIELD CURRENT MEASURED IS TOO LOW." }, { "mdr_text_key": "383083391", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "376091758", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A PROCEDURE, THE OPERATING ROOM STAFF CONTACTED TECHNICAL SUPPORT BECAUSE THE SYSTEM'S ARMS WERE LOCKING UP, AND AN ERROR WAS DISPLAYED, INDICATING A PROBLEM WITH THE ENERGY STORAGE MODULE (ESM). BEFORE CONTACTING SUPPORT, THE CUSTOMER HAD ALREADY RESTARTED THE SYSTEM, WHICH ALLOWED THEM TO CONTINUE FOR ABOUT FIVE MINUTES BEFORE THE ERROR RECURRED. THE TECHNICAL SUPPORT REPRESENTATIVE ADVISED PERFORMING ANOTHER SYSTEM RESTART TO RESET THE ESM. THEY NOTED THAT THE ERROR WAS RECOVERABLE FOR THE SYSTEM BUT NOT FOR THE ESM, NECESSITATING A RESTART TO RESTORE MONOPOLAR ENERGY CAPABILITY. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY. THE PATIENT TOLERATED THE CONVERSION. NO ADDITIONAL INFORMATION WAS PROVIDED." }, { "mdr_text_key": "376091759", "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 ENERGY SHIELD MONITOR (ESM) WAS EXCHANGED, RESOLVING THE ISSUE, AND THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE THE ESM TO PERFORM FAILURE ANALYSIS. HOWEVER, THE FAILURE ANALYSIS INVESTIGATION IS CURRENTLY IN PROCESS." } ], "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": "08/27/2025" } ] }