{ "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": "2955842-2026-21582", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20260416", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20260325", "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": "", "date_added": "20260416", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20200227", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "291490", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260416", "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": "380941-40", "catalog_number": "N/A", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20260402", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "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": [ "Output Problem" ], "reporter_state_code": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/27/2026", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20260814", "health_professional": "Y", "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": "20260416", "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" ] } ], "distributor_city": "", "date_report": "20260609", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "24896636", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20260325", "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": "398574942", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) PERFORMED A SITE VISIT AND REPLACED THE ENERGY SHIELD MONITOR (ESM) TO RESOLVE THE ISSUE. THE PRODUCT HAS BEEN RECEIVED A FOR FAILURE ANALYSIS EVALUATION. HOWEVER, THE FAILURE ANALYSIS INVESTIGATION HAS NOT BEEN COMPLETED AT THE TIME OF THIS REPORT. THEREFORE, THE CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. SYSTEM LOGS CONFIRMED REPEATED ESM FAILURES." }, { "mdr_text_key": "398574943", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A SINGLE PORT (SP) DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER CALLED TECHNICAL SUPPORT STATING THE ENERGY SHIELD MONITOR (ESM) FAULTED AND THE LEDS TURNED YELLOW. THE CUSTOMER POWER CYCLED AND THE SYSTEM RESTORED THE ESM HOWEVER IT FAULTED AGAIN AFTER A FEW MINUTES. THE TECHNICAL SERVICE ENGINEER (TSE) WALKED THE CUSTOMER THROUGH POWERING OFF AND CYCLING THE VISION SIDE CART (VSC) BREAKER AND THE ESM POWER CONNECTIONS AND POWERED UP WITHOUT FAULTS. THE ESM FUNCTIONED PROPERLY FOR A FEW MINUTES AND THEN FAULTED AGAIN. THE CUSTOMER STATED THEY MAY SWITCH TO THE MULTIPORT DA VINCI XI AND USE SINGLE PORT TECHNIQUE. ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER FOR ADDITIONAL INFORMATION; HOWEVER, NO RESPONSE HAS BEEN RECEIVED." }, { "mdr_text_key": "404286088", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "404286089", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE ENERGY SHIELD MONITOR (ESM) WAS RECEIVED FOR DURING FAILURE ANALYSIS. LOGS SHOWED MULTIPLE ERRORS INDICATING THAT THE SHIELD CURRENT CIRCUIT WAS NOT WORKING, CONFIRMING THE FAULT OCCURRED IN THE FIELD. DURING VISUAL INSPECTION, NO ISSUES WERE SEEN THAT WOULD BE RELEVANT TO THE REPORTED PROBLEM. THE UNIT WAS INSTALLED ONTO AN IN-HOUSE SYSTEM WHERE THE UNIT HAD FUNCTIONED AS DESIGNED. THE UNIT HAD BEEN TESTED USING CAUTERY INSTRUMENTS, IDLED FOR ABOUT 2 HOURS, AND POWER CYCLED 10 TIMES; HOWEVER, NO FAULTS OR ERRORS WERE SEEN." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "06/09/2026" } ] }