{ "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": "2955842-2023-19740", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20231109", "manufacturer_address_2": "", "pma_pmn_number": "K131861", "date_of_event": "20231013", "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", "Foreign", "Distributor" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "IT", "manufacturer_contact_area_code": "408", "date_added": "20231110", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20190201", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "92252", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20231109", "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": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "380723-05", "catalog_number": "N/A", "lot_number": "N/A", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "R", "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": [ "Visual Prompts will not Clear", "Visual Prompts will not Clear" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250806", "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": "20231109", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "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": "20231013", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "18107903", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20231013", "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": "327866077", "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 SITE REPORTED THAT HEAD SENSOR SOMETIMES NOT WORKING AND SYSTEM ASKS TO OPEN AND CLOSE GRIP MASTER TOOL MANIPULATOR (MTMS). INTUITIVE TECHNICAL SUPPORT ENGINEER (TSE) CHECKED THE LOGS, THERE ARE ONLY THE COMMUNICATIONS ERRORS. SITE PERFORMED DIFFERENT ACTIONS TO TROUBLESHOOT THE ISSUE PER TSE RECOMMENDATION. BUT, PROBLEM DID NOT RESOLVE AND THE SURGEON CONVERTED THE SURGERY IN OPEN. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL (IS) CONTACTED THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THIS EVENT: THE PROCEDURE WAS CONVERTED TO OPEN AS THE SURGEON COULD NOT MOVE THE MTMS ON THE CONSOLE FLUENTLY. EVEN IF HE WAS NOT MOVING HIS HEAD FROM THE 3D VIEWER, EVERY 2-3 MINUTES, THE SYSTEM RESPONDED AS IF THE DOCTOR JUST SAT AT THE CONSOLE, BLOCKING THE INSTRUMENTS AND THE MASTERS AND ASKING THE SURGEON TO MOVE THE GRIP. THE PROCEDURE WAS NOT CONVERTED FOR INTRA OPERATIVE COMPLICATIONS. THE PATIENT TOTALLY TOLERATED THE CHANGE. THERE WAS NO ANY INJURY TO THE PATIENT. SYSTEM MALFUNCTION OCCURRED PRIOR TO CONVERSION BUT, IT DID NOT LEAD TO ANY PATIENT HARM. ACCORDING TO THE SURGEON, THERE WAS A PROBLEM TO THE SENSORS IN THE 3D VIEWER WHICH CAUSED OR CONTRIBUTED TO THE REPORTED SYSTEM MALFUNCTION. THE SYSTEM WAS INSPECTED PRIOR TO USE AND THERE WAS NO ANY ISSUES NOTED DURING SET UP OF THE SYSTEM. WHEN THE ISSUE OCCURRED THE PROCEDURE WAS IN PROGRESS FOR 1 HOUR MORE OR LESS. THERE WAS NO POST-OPERATIVE COMPLICATIONS." }, { "mdr_text_key": "327866078", "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. SURGEON SIDE CONSOLE (SSC) TOUCHPAD CALIBRATION AND FUNCTIONAL CHECK WAS PERFORMED, SIMULATING NORMAL SYSTEM OPERATION. TX AND RX HEADS ENSOR FUNCTIONAL CHECK PERFORMED WITH REVIEW OF ERROR LOGS IN MAINTENANCE MODE. BOTH SENSORS WERE TESTED DURING SYSTEM VERIFICATION AND ARE FULLY FUNCTIONAL. SYSTEM TESTED TO ORIGINAL MANUFACTURER SPECIFICATIONS. NO PART REPLACEMENT REQUIRED. SYSTEM INSPECTED, TESTED AND VERIFIED AS READY FOR USE. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS CONFIRMED WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE." } ], "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": "" } ] }