{ "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": "2955842-2025-29791", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20250721", "manufacturer_address_2": "", "pma_pmn_number": "K131861", "date_of_event": "20250627", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "PHYSICIAN", "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": "FR", "manufacturer_contact_area_code": "408", "date_added": "20250721", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20230405", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2433696", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250721", "brand_name": "DA VINCI XI", "generic_name": "SURGEON SIDE CONSOLE, RECONDITIONED", "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": "380723-16", "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": "00886874115374", "udi_public": "(01)00886874115374", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Failure to Power Up", "Failure to Power Up" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/14/2025", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20251103", "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": "20250721", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "71 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Tissue Injury", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20250627", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "22553717", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250627", "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": "384063962", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE DA VINCI PRODUCTS TO PERFORM FAILURE ANALYSIS. THE POWER SUPPLY WAS RETURNED FOR FAILURE ANALYSIS, AND THE REPORTED POWER COMPLAINT WAS NOT CONFIRMED. UPON VISUAL INSPECTION, THE SQUARE PLATE WASHER FOR TERMINAL SCREWS WERE MISSING. THE POWER SUPPLY WAS INSTALLED AND TESTED ON THE PRINTED CIRCUIT ASSEMBLY (PCA) TEST SYSTEM. THE SYSTEM STARTED WITHOUT ANY ERRORS. THEN 10 POWER CYCLES WERE PERFORMED, AND THE SYSTEM WORKS NORMALLY WITHOUT ANY ISSUES. THE COMPLAINT WAS NOT CONFIRMED BASED ON FAILURE ANALYSIS. THE CFG GPD WAS RETURNED FOR FAILURE ANALYSIS AND ANALYZED. LOGS SHOWED NO DATA TO INDICATE THAT THE FAULT HAD OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WERE RELATED TO THE REPORTED ISSUE. THE GPD WAS INSTALLED ONTO A GOLDEN IS4000 SYSTEM WHERE WAS TRIGGERED INDICATING FAULT ON THE GPD. THE UNIT WAS NOT BOOTED. FAILURE ANALYSIS WAS ABLE TO REPLICATE THE REPORTED EVENT." }, { "mdr_text_key": "375381511", "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 GENERIC POWER DISTRIBUTOR (GPD) WAS REPLACED BY THE FSE TO RESOLVE THE CUSTOMER-REPORTED EVENT. SYSTEM WAS THEN TESTED TO ORIGINAL EQUIPMENT MANUFACTURER SPECIFICATIONS AND VERIFIED AS READY FOR USE. THE ISI DEVICE HAS NOT BEEN RECEIVED. A REVIEW OF THE SYSTEM LOGS DID NOT REVEAL ANY ERRORS PERTAINING TO THE ALLEGED COMPONENT INVOLVED IN THE CUSTOMER-REPORTED EVENT." }, { "mdr_text_key": "375381512", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT PRIOR TO THE START - POST ANESTHESIA DA VINCI-ASSISTED RENAL TUMORECTOMY PROCEDURE, THE SURGEON SIDE CONSOLE (SSC) WOULD NOT POWER ON, DESPITE BEING POWERED DURING SYSTEM INSTALLATION. THE PORTS WERE IN PLACE WHEN THE PROBLEM WAS DISCOVERED. VARIOUS TROUBLESHOOTING STEPS WERE TAKEN, INCLUDING CHANGING THE POWER CORD LOCATION MULTIPLE TIMES, TOGGLING THE SSC SWITCH BREAKER, SWAPPING THE POWER CORD LOCATION WITH A KNOWN WORKING ONE, WIGGLING THE POWER CORD, AND ENSURING THE POWER CORD WAS PROPERLY SEATED IN THE CONSOLE. THE CUSTOMER HAD ONLY ONE SSC, AND IT WAS DETERMINED THAT A REPLACEMENT OF THE CONSOLE POWER CORD WAS NOT POSSIBLE BY THE BIOMED OR ELECTRICAL DEPARTMENT. SUBSEQUENTLY, A SALES REPRESENTATIVE CALLED TO REQUEST AN UPDATE, AND IT WAS CONFIRMED THAT ON SITE TROUBLESHOOTING WITH SPARE PART REPLACEMENT WAS NECESSARY TO RESOLVE THE ISSUE. THE PROCEDURE WAS ABORTED POST-ANESTHESIA AND PORT PLACEMENT, AND IT WAS UNKNOWN IF OR WHEN THE PROCEDURE WOULD BE RESCHEDULED." } ], "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": "09/09/2025" } ] }