{ "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": "2955842-2025-47904", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20251212", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20251119", "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", "Foreign", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "BE", "manufacturer_contact_area_code": "408", "date_added": "20251212", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20240214", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2849035", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20251212", "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": "380941-50", "catalog_number": "N/A", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "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": "02/25/2026", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20260504", "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": "20251212", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "NA", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Tissue Injury", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20260320", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "23794506", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20251119", "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": "396306567", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UPDATED FIELDS: D9, H2, H3, H6, AND H11. DEVICE EVALUATION: INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE ENERGY SHIELD MONITOR (ESM) INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE ESM WAS ANALYZED AND FOUND TO HAVE NO FUNCTIONAL ISSUES WHEN INSTALLED ON AN IN-HOUSE SYSTEM AND WAS WORKING AS EXPECTED. A REVIEW OF THE SITE¿S SYSTEM LOGS CONFIRM AN ERROR INDICATING THE ESM WAS NOT PRESENT." }, { "mdr_text_key": "396306568", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "387616306", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY, THE NURSE CALLED TO REPORT THAT THE ENERGY SHIELD MONITOR (ESM) WAS FLASHING AND SHOWING ERRORS DURING THE SURGERY. PRIOR TO CONTACTING TECHNICAL SUPPORT, THE CUSTOMER ATTEMPTED TO REBOOT THE SYSTEM, BUT THERE WAS NO IMPROVEMENT. THE TECHNICAL SUPPORT ENGINEER (TSE) TRIED TO CHECK LIVE EVENTS, BUT THE SYSTEM WAS NOT CONNECTED TO ONSITE. THE TSE GUIDED THE CUSTOMER TO CHECK THE CABLE CONNECTIONS, WHICH APPEARED TO BE CORRECT, AND THE CUSTOMER EXPLAINED THAT THEY HAD BEEN USING THE SYSTEM NORMALLY BEFORE THE ERRORS STARTED. THE TSE INSTRUCTED THE CUSTOMER TO POWER DOWN THE SYSTEM, EXERCISE THE BREAKER, PUSH THE ESM POWER CABLE IN, AND CHECK ALL POWER CABLES IN THE VISION SIDE CART (VSC) POWER STRIP; HOWEVER, THE ESM STILL DID NOT TURN ON. THE TSE ASKED THE CUSTOMER IF THEY HAD A SPARE POWER CABLE THAT COULD BE CONNECTED DIRECTLY TO THE ESM AND THE WALL, BUT EVEN AFTER ATTEMPTING THIS, THE ESM DID NOT TURN ON. THE TSE EXPLAINED THAT THE ESM APPEARED TO BE NON-FUNCTIONAL, AND THE NURSE STATED THEY WOULD CONVERT TO AN ALTERNATIVE METHOD, AS THE CUSTOMER WAS IN THE ROOM AND THEY NEEDED TO CONTINUE THE PROCEDURE AS SOON AS POSSIBLE. THE SINGLE PORT (SP) PROCEDURE WAS REPORTEDLY CONVERTED TO A LAPAROSCOPIC PROCEDURE." }, { "mdr_text_key": "387616307", "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 WENT ON SITE AND REPLACED THE ENERGY SHIELD MONITOR (ESM) DUE TO THE NODE MISSING ERROR THAT WAS FOUND IN THE LOGS. NO ISSUES WERE NOTED DURING THE SYSTEM POWER ON. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID NOT RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS." } ], "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": "03/20/2026" } ] }