{ "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": "2955842-2025-38999", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20250924", "manufacturer_address_2": "", "pma_pmn_number": "K131861", "date_of_event": "20250829", "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": "GM", "manufacturer_contact_area_code": "408", "date_added": "20250924", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20210629", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "607804", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250924", "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": "380723-11", "catalog_number": "380723", "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": "", "udi_public": "", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Display or Visual Feedback Problem", "Display or Visual Feedback Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "10/25/2025", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20251231", "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": "20250924", "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": "20251120", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "23135099", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250829", "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": "380883971", "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 WAS ABLE TO REPRODUCE THE CUSTOMER REPORTED ISSUE. THE FSE REPLACED MULTIPLE PARTS TO RESOLVE THE ISSUE OF THE SSC GOING BLACK DURING A PROCEDURE. 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." }, { "mdr_text_key": "380883972", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SURGEON SIDE CONSOLE (SSC) WENT BLACK ON BOTH THE VIEWER AND THE TOUCHPAD. THE CUSTOMER CONTACTED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) FOR ASSISTANCE. TROUBLESHOOTING FIRST CONSISTED OF CHECKING THE SYSTEM LOGS, WHICH SHOWED THE SSC WAS NOT CONNECTED TO THE VISION SIDE CART (VSC). THE TSE INSTRUCTED THE CUSTOMER TO SHUT DOWN THE SYSTEM, CLEAN THE BLUE FIBER CABLE AT BOTH THE SSC AND VSC, AND RESTART. DESPITE THESE EFFORTS, THE SSC REMAINED DISCONNECTED ACCORDING TO THE VSC, WITH THE POWER BUTTON BLINKING BLUE AND NO DISPLAY ON THE SCREENS, THOUGH FAN NOISE REMAINED PRESENT. ATTEMPTS TO START IN STAND-ALONE MODE DID NOT RESTORE FUNCTION. THE SURGEON THEN ELECTED TO ABORT THE PROCEDURE." }, { "mdr_text_key": "386413120", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UPDATED FIELDS: D9, H2, H3, H6, AND H11 DEVICE EVALUATION: THE POWER SUPPLY WAS RETURNED FOR FAILURE ANALYSIS AND THE REPORTED POWER COMPLAINT WAS NOT CONFIRMED. UPON VISUAL INSPECTION, THE FAN LOOKED DUSTY. THE POWER SUPPLY WAS TESTED AND THE SYSTEM STARTED WITHOUT ANY ERRORS. TEN POWER CYCLES WERE PERFORMED AND THE SYSTEM WORKED NORMALLY WITHOUT ANY ISSUES. THE GENERIC POWER DISTRIBUTOR (GPD) WAS ALSO RETURNED FOR FAILURE ANALYSIS. A VISUAL INSPECTION FOUND NO ISSUES RELATED TO THE REPORTED ISSUE. THE GPD WAS INSTALLED IN A TEST SYSTEM WHERE IT FUNCTIONED AS EXPECTED. THE GENERIC CART CONTROLLER (GCC) WAS ALSO RETURNED FOR FAILURE ANALYSIS. A VISUAL INSPECTION FOUND NO ISSUES RELATED TO THE REPORTED EVENT. THE GCC WAS INSTALLED ON TEST SYSTEM. UPON POWER ON, THE GCC WAS NOT VISIBLE ON A LAPTOP APPLICATION. THE SURGEON SIDE CONSOLE (SSC) DID NOT POWER ON, THERE WAS NO POWER OUTPUT. THERE WAS A RED LED LIGHT ON THE GCC, INDICATIVE THAT THE GCC FAILED. THE SURGEON BACK PLANE (SBP) WAS INSTALLED ONTO A TEST SYSTEM WHERE THE COMPONENT FUNCTIONED AS EXPECTED. THE TEST SYSTEM WAS SET TO RUN 10 POWER CYCLES AND SITTING IDLE FOR ONE HOUR. ONCE TESTING WAS COMPLETED, THE SYSTEM ERROR LOGS WERE INSPECTED, BUT NO ERROR COULD BE IDENTIFIED." }, { "mdr_text_key": "386413121", "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": "11/20/2025" } ] }