{ "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": "2955842-2024-20356", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20241015", "manufacturer_address_2": "", "pma_pmn_number": "K131861", "date_of_event": "20240918", "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": "20241015", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20240604", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1322363", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20241015", "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": "380723-17", "catalog_number": "N/A", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20241003", "device_report_product_code": "NAY", "device_age_text": "", "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": [ "No Display/Image", "No Display/Image" ], "reporter_state_code": "OR", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250821", "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": "20241015", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "NA", "patient_sex": "Prefer Not To Disclose", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Tissue Injury", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20240918", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "20456701", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20240918", "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": "354261045", "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 ISI FSE CONTACTED THE CSR AND WENT THROUGH RECOVERY FOR THE SYSTEM WITH NO CHANGE FOR THE RIGHT EYE ON THE SCREEN OF THE SSC. FURTHER INVESTIGATION WITH ENDOSCOPE FROM LEFT EYE TO RIGHT EYE AND 3D TO 2D AND TRYING TO GET TEST SCREEN, SHOWED RIGHT SCREEN OF SSC NEEDED INVESTIGATION. THE ISI FSE WENT ON SITE AND CONFIRMED THAT THE RIGHT EYE WAS BLACK, AND THE MONITOR WAS BROKEN AND REPLACED THE HIGH-RESOLUTION STEREO VIEWER (HRSV) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. DURING IN-HOUSE TESTING THE MONITOR WAS INSTALLED AND TESTED IN THE PRINTED CIRCUIT ASSEMBLY (PCA) TEST SYSTEM. IT STARTED AND FAILED WITHOUT VIDEO ON THE DISPLAY." }, { "mdr_text_key": "354261046", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED INGUINAL HERNIA SURGICAL PROCEDURE, THE SITE CONTACTED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT THE RIGHT EYE OF THE CONSOLE WAS BLACK. THE CUSTOMER STATED STAFF WAS IN THE PROCESS OF RESEATING THE ENDOSCOPE AND PERFORMING A POWER CYCLE OF THE SYSTEM, BUT THE ISSUE REMAINED. THE ISI TSE REVIEWED THE LOGS AND FOUND ENDOSCOPE COMMUNICATION ISSUES. THE TSE RECOMMENDED A HARD POWER CYCLE OF THE CONSOLE WHEN POSSIBLE. THE CUSTOMER WAS PLANNING TO LET THE STAFF KNOW AND CALL BACK IF THE HARD POWER CYCLE WOULD NOT RESOLVE THE ISSUE AND THE CALL ENDED. ISI CLINICAL SALES REPRESENTATIVE (CSR) CALLED BACK IN TO REPORT THEY TRIED A HARD REBOOT, BUT THE RIGHT EYE OF THE CONSOLE WAS STILL BLACK. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM WAS POWERED ON; ARMS WERE CHECKED FOR FUNCTIONALITY DURING THE DRAPING PROCESS. INTEGRATED ELECTROSURGICAL UNIT (IESU) POWERED ON AND FUNCTIONED WITH VISION TOWER. THE SURGEON WAS LOGGED INTO THE SURGEON CONSOLE WITHOUT ISSUE BUT VISION THROUGH THE SURGEON CONSOLE WAS NOT CHECKED. THE SYSTEM POWERED ON WITHOUT ANY ERROR MESSAGES OR FAULTS. THE SYSTEM WAS POWER CYCLED. ENDOSCOPES WERE SWITCHED AND THE CSR CHECKED 2D VS 3D SETTINGS AND CALLED INTO DV STAT TECHNICAL SUPPORT. THE PROCEDURE WAS COMPLETED ROBOTICALLY. ONE ADDITIONAL LAPAROSCOPIC PORT WAS PLACED FOR SUCTION. NO INJURY WAS REPORTED." } ], "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": "" } ] }