{ "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": "2955842-2025-26518", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20250624", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20250530", "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", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20250624", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20220311", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "957500", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250624", "brand_name": "DA VINCI SP", "generic_name": "SURGEON SIDE CONSOLE", "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": "380940-45", "catalog_number": "N/A", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20250605", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "00886874114735", "udi_public": "(01)00886874114735", "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": "OK", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/24/2025", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20250804", "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": "20250624", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "72 YR", "patient_sex": "Male", "patient_weight": "120 KG", "patient_ethnicity": "Non Hispanic", "patient_race": "Black Or African American", "patient_problems": [ "Unspecified Tissue Injury", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20250530", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "22318335", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250530", "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": "373251436", "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 REPLACED THE POWER SUPPLY IN THE SURGEON SIDE CONSOLE AND THE SYSTEM WAS VERIFIED. FURTHER ACTIONS INCLUDED AN EXCHANGE OF PARTS, SPECIFICALLY REPLACING A PWR SUPPLY WITH A REDUNDANT MGPS UNIT THAT HAD REDUCED FAN SPEED, WHICH SUCCESSFULLY RESOLVED THE ISSUE, THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS; HOWEVER, THE FAILURE ANALYSIS INVESTIGATION HAS NOT BEEN COMPLETED AT THE TIME OF THIS REPORT." }, { "mdr_text_key": "373251437", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ADRENALECTOMY PROCEDURE, THE INTUITIVE SURGICAL, INC, (ISI) CLINICAL SALES REPRESENTATIVE (CSR) CONTACTED A TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED THAT THE CONSOLE WOULD NOT POWER ON AFTER THE CUSTOMER HAD ALREADY DOCKED TO THE PATIENT. THE CSR CHECKED THE WALL POWER, MOVED THE POWER CORD TO ANOTHER OUTLET, AND VERIFIED THAT THE WALL POWER WAS GOOD. THE CONSOLE BREAKER WAS CHECKED AND CYCLED ON AND OFF, BUT THE CONSOLE STILL DID NOT POWER ON. THE SYSTEM LOGS INDICATED THAT NO CONSOLE WAS CONNECTED, SUGGESTING A POSSIBLE MEDICAL GRADE POWER SUPPLY (MGPS) FAILURE. THE ENTIRE SYSTEM WAS SWAPPED OUT, AND THE PROCEDURE WAS CONVERTED FROM A SINGLE PORT TO A MULTI-PORT PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A XI SYSTEM." }, { "mdr_text_key": "376702548", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE POWER SUPPLY UNIT WAS EVALUATED BY FAILURE ANALYSIS ON 24-JUN-2025. UPON VISUAL INSPECTION, THE UNIT HAD MINOR YELLOW DISCOLORATION. THE POWER SUPPLY WAS INSTALLED ON THE PRINTED CIRCUIT ASSEMBLY (PCA) TEST SYSTEM BUT WOULD NOT POWER ON AND HAD NO VOLTAGE. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE REVEALED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT." }, { "mdr_text_key": "376702549", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." } ], "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": "07/15/2025" } ] }