{ "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": "2955842-2025-01541", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20250213", "manufacturer_address_2": "", "pma_pmn_number": "K131861", "date_of_event": "20250117", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20250213", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20180508", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1207806", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250213", "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": "380723-02", "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": "N", "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": [ "Energy Output Problem", "Energy Output Problem" ], "reporter_state_code": "NV", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250822", "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": "20250213", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention", " H" ], "patient_age": "NA", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Tissue Injury", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20250120", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "21375048", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250120", "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": "363545301", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. NO SITE VISIT WAS CONDUCTED. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) FOLLOWED UP WITH THE ROBOTICS COORDINATOR AND THERE HAD BEEN NO FURTHER ISSUES AND THERE WERE NO ISSUES IN THE SYSTEM LOGS. INTUITIVE SURGICAL, INC. (ISI) RECEIVED A VIDEO CLIP RELATED TO THE ALLEGED COMPLAINT. A REVIEW OF THE VIDEO CLIP WAS CONDUCTED, AND THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: IN THE VIDEO, IT WAS CONFIRMED THAT THE MONOPOLAR CURVED SCISSORS (MCS) IN ARM 3 WAS ACTIVATED AT 0:11, 0:16, AND 0:24, WHILE THE NARRATING USER EXPLAINS THAT THEY MEANT TO ACTIVATE THE FORCE BIPOLAR IN ARM 1. THE USER INTERFACE (UI) IS CONSISTENT WITH THE USER'S FOOT HOVERING OVER AND THEN PRESSING THE PEDAL ASSOCIATED WITH THE MCS IN ARM 3, NOT THE FORCE BIPOLAR IN ARM 1. AT 0:32, THE SURGEON IS ABLE TO SUCCESSFULLY ACTIVATE THE FORCE BIPOLAR AND DOES NOT APPEAR TO EXPERIENCE FURTHER ISSUES. WITHOUT SEEING THE FOOT PEDALS, IT COULD NOT BE CONFIRMED WHICH WERE BEING PRESSED. THE EVENT INVESTIGATION IS IN PROGRESS." }, { "mdr_text_key": "363545302", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE, THE MONOPOLAR ENERGY INSTRUMENT WAS ACTIVATED INSTEAD OF THE INTENDED BIPOLAR INSTRUMENT. BOTH THE MONOPOLAR AND BIPOLAR ENERGY SETTINGS WERE SET TO 4. WHILE DISSECTING THE URETER, THE SURGEON HAD THE FORCE BIPOLAR INSTRUMENT IN THE LEFT HAND AND THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT IN THE RIGHT. WHILE ATTEMPTING TO CAUTERIZE WITH THE BIPOLAR ENERGY USING THE FORCE BIPOLAR INSTRUMENT, THE MCS INSTRUMENT HAD INADVERTENTLY FIRED CAUSING AN INJURY TO THE URETER. UPON THE INCORRECT ACTIVATION OF THE MCS INSTRUMENT, THE SURGEON CHECKED THE FOOT PEDALS TO ENSURE THEY WERE PRESSING THE CORRECT ONES, WHICH WAS CONFIRMED TO BE CORRECT. THE FORCE BIPOLAR INSTRUMENT WAS THEN TESTED SEPARATELY AND INITIALLY DID NOT ADMINISTER BIPOLAR ENERGY, BUT THE PROBLEM RESOLVED ITSELF SHORTLY AFTER. A UROLOGIST WAS CONSULTED, RESULTING IN A 15-MINUTE DELAY IN THE PROCEDURE, AND IT WAS DETERMINED THAT NO FURTHER INTERVENTION WAS REQUIRED. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITHOUT FURTHER COMPLICATIONS. POSTOPERATIVELY, THE PATIENT WAS HOSPITALIZED FOR TWO ADDITIONAL DAYS TO ENSURE THERE WERE NO FURTHER COMPLICATIONS TO THE URETER DUE TO THE THERMAL INJURY. TWO COMPUTED TOMOGRAPHY (CT) SCANS SHOWED NO STRICTURE OR LEAK OF THE URETER. THE PATIENT IS EXPECTED TO MAKE A FULL RECOVERY BUT WILL CONTINUE TO BE MONITORED BY THE UROLOGIST." } ], "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": "" } ] }