{ "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": "2955842-2024-12511", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20240319", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20240223", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "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": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20240319", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20230207", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "965953", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240319", "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": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "380941-45", "catalog_number": "N/A", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20240305", "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": [ "Visual Prompts will not Clear", "Visual Prompts will not Clear" ], "reporter_state_code": "MS", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "03/26/2024", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "", "date_changed": "20250727", "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": "20240319", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20240223", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "18936936", "removal_correction_number": "N/A", "number_devices_in_event": "", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "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": "338073448", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS ABLE TO REPRODUCE THE ISSUE AND REPLACED THE VIDEO PROCESSOR (VP) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND WAS READY FOR USE. ISI HAS RECEIVED THE VP, BUT FAILURE ANALYSIS HAS NOT YET BEEN COMPLETED. THEREFORE, THE ROOT CAUSE OF THE REPORTED FAILURE MODE HAS NOT YET BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED AFTER FAILURE ANALYSIS INVESTIGATION AND IF ADDITIONAL INFORMATION IS OBTAINED." }, { "mdr_text_key": "338073449", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SINGLE-PORT (SP) SURGICAL PROCEDURE, THE SYSTEM DISPLAYED A MESSAGE INDICATING THAT THE VIO INTEGRATED ELECTROSURGICAL GENERATOR UNIT (IESU) WAS NOT CONNECTED AND HAD A DIRTY FIBER CABLE MESSAGE. THE CUSTOMER CHECKED THE CABLE CONNECTIONS TO THE IESU, SURGEON SIDE CONSOLES (SSC) AND THE PATIENT SIDE CART (PSC) PRIOR TO CALLING IN THE ISSUE. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) REVIEWED THE SYSTEM LOGS AND NOTED A 307 ERROR POINTING TO THE VIDEO PROCESSOR (VP). THE TSE HAD THE CUSTOMER POWER OFF THE SYSTEM AND ENSURE THAT THE FIBER CABLES WERE FULLY SEATED ON THE BACK OF THE CORE AND VP, RESEAT THE ORANGE FIBER CABLES, AND ENSURE THAT THE BREAKERS OF THE VP AND ENDOSCOPE CONTROLLER (EC) WERE ON. THE SYSTEM POWERED ON WITH NO OTHER ERRORS, BUT LATER THE ERRORS RETURNED. THE TSE HAD THE CUSTOMER POWER CYCLE THE COMPONENTS AGAIN AND RESEAT THE FIBER CABLES. THE VP FAULTED AGAIN AND INDICATED A RED FIBER CABLE STATUS ON THE CORE TO THE VP. THE CUSTOMER USED A FIBER CABLE FROM THE SIMULATOR AND THE ERRORS CLEARED AGAIN. THE CUSTOMER THEN CALLED LATER AND REPORTED THAT THE VP FAULT RETURNED AS A NON-RECOVERABLE FAULT. THE SURGEON WAS POSSIBLY GOING TO CONVERT THE PROCEDURE TO A MULTI-PORT PROCEDURE USING AN XI SYSTEM. ISI FOLLOWED UP WITH THE ISI CLINICAL TERRITORY ASSOCIATE (CTA) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CTA CONFIRMED THAT THERE WERE FOUR ADDITIONAL PORTS CREATED DUE TO THE CONVERSION FROM AN SP SYSTEM TO AN XI SYSTEM. THE CONVERSION AND ADDITION OF PORTS WAS THE ONLY CHANGE AND PATIENT OUTCOME WAS REPORTED TO BE THAT NO HARM CAME TO THE PATIENT. THE CUSTOMER WAS UNSURE IF THERE WAS ANY CHANGE IN THE PATIENT'S CARE PLAN DUE TO THE CONVERSION. THE CUSTOMER DID CONFIRM THAT THE CONVERSION OCCURRED DUE TO THE NON-RECOVERABLE HARD FAULT THAT HAPPENED ON THE SP SYSTEM. THE PROCEDURE WAS COMPLETED USING THE XI SYSTEM THAT WAS BROUGHT IN TO CONTINUE." }, { "mdr_text_key": "341020039", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) RECEIVED A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS EVALUATION. THE VIDEO PROCESSOR (VP) WAS INSTALLED INTO THE TEST SYSTEM AND RUN THROUGH A VIDEO TEST, 1 MINUTE SINE CYCLE, 10 POWER CYCLES & SITTING IDLE FOR 1 HOUR. DURING THE TESTS, THE TECHNICIAN REPLICATED THE REPORTED FAILURE. THE COMPLAINT WAS CONFIRMED BASED ON FAILURE ANALYSIS." }, { "mdr_text_key": "341020040", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/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": "", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "04/24/2024" } ] }