{ "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": "2955842-2026-01155", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20260116", "manufacturer_address_2": "", "pma_pmn_number": "K131861", "date_of_event": "20251223", "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", "Foreign", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "IN", "manufacturer_contact_area_code": "", "date_added": "20260116", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20230428", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "156874", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260116", "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": "380723-15", "catalog_number": "N/A", "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": "00886874115374", "udi_public": "(01)00886874115374", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Output Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "03/31/2026", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20260504", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20260116", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20260422", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "24094328", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20251223", "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": "390441348", "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 REMOTE ARM CONTROLLER BOARDS (RAC) TO RESOLVE THE ISSUE WITH THE ERROR WHICH POINTING TO THE VOLTAGE BEING OUT OF RANGE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS NOT RECEIVED A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS." }, { "mdr_text_key": "390441349", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THERE WAS AN ERROR POINTING TO THE LEFT MASTER TOOL MANIPULATOR (MTM). THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) REPORTED A REPEAT RECOVERABLE FAULT WITH A PROMPT MESSAGE TO DISABLE THE LEFT MASTER TOOL MANIPULATOR (MTM). THE SYSTEM WAS STARTED AGAIN AND THE ISSUE CONTINUED. THE SITE ABANDONED THE CASE AFTER PORTS HAD BEEN PLACED. THE SYSTEM WAS NOT CONNECTED THROUGH ONSITE DURING THE CALL. THE PROCEDURE WAS ABORTED. ISI FOLLOWED UP AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: UPON REVIEW, THE SYSTEM FUNCTIONALITY WAS NOT CHECKED UPON POWERING ON. FURTHERMORE, THE SYSTEM DID NOT POWER ON WITHOUT ERRORS; ERRORS WERE PRESENT FROM THE START. DESPITE THESE ISSUES, TECHNICAL SUPPORT WAS NOT CONTACTED FOR TROUBLESHOOTING AT THE TIME OF THE ISSUE FOR FULL TROUBLESHOOTING. FACED WITH THESE CHALLENGES, THE PROCEDURE WAS ABORTED ALTOGETHER. NO FURTHER ATTEMPTS WERE MADE TO RESOLVE THE REPORTED ISSUE, AND THE DECISION WAS MADE TO END THE PROCESS RATHER THAN CONTINUE OR CONVERT TO AN ALTERNATIVE METHOD. CONSEQUENTLY, THE PROCEDURE WAS NOT COMPLETED ROBOTICALLY OR CONVERTED TO ANOTHER ROBOTIC PLATFORM, OPEN, OR TRADITIONAL LAPAROSCOPIC SURGERY; IT WAS SIMPLY ABORTED. TECHNICAL SUPPORT WAS NOT CONTACTED PRIOR TO ABORTING THE PROCEDURE." }, { "mdr_text_key": "399232226", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UPDATED FIELDS: D9, G3, G6, H2, H3, H6, AND H11. DEVICE EVALUATION: INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE REMOTE ARM CONTROLLER (RAC) INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE RAC WAS ANALYZED AND FOUND TO HAVE NO FUNCTIONAL ISSUES WHEN INSTALLED ON AN IN-HOUSE SYSTEM. THE SYSTEM WAS POWER CYCLED 10 TIMES AND LEFT TO SIT IDLE FOR 1 HOUR WITHOUT ISSUES. THE MASTER TOOL MANIPULATOR (MTM) WAS DRIVEN MANUALLY AND THE RAC FUNCTIONED AS EXPECTED AND SMOOTHLY. ONCE TESTING WAS COMPLETED, THE SYSTEM ERROR LOGS WERE INSPECTED, BUT NO ERROR COULD BE IDENTIFIED." }, { "mdr_text_key": "399232227", "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": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "04/22/2026" } ] }