{ "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": "2955842-2025-23476", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20250606", "manufacturer_address_2": "", "pma_pmn_number": "K143132", "date_of_event": "20250514", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "NURSE", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "KS", "manufacturer_contact_area_code": "408", "date_added": "20250606", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20241121", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2129748", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250606", "brand_name": "DA VINCI", "generic_name": "HARMONIC ACE", "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": "480275-10", "catalog_number": "480275", "lot_number": "L12241121 0101", "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": "10886874112738", "udi_public": "(01)10886874112738(17)261130(10)L12241121", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Detachment of Device or Device Component", "Detachment of Device or Device Component" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/21/2025", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20251001", "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": "20250606", "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": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20250514", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "22158797", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250514", "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": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "371851960", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED THYMECTOMY PROCEDURE, THE TIP OF THE HARMONIC ACE INSTRUMENT BROKE AND A FRAGMENT FELL INSIDE THE PATIENT. THE INSTRUMENT BROKE WHILE THE SURGEON WAS DISSECTING. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE, WHICH WAS VISUALLY CONFIRMED. THE PROCEDURE WAS COMPLETED ROBOTICALLY, USING A BACKUP HARMONIC ACE INSTRUMENT. NO ADDITIONAL SURGICAL PROCEDURE OR POST-OPERATIVE TESTS WERE PERFORMED. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO ANY POST-SURGICAL COMPLICATIONS RELATED TO A RETAINED FOREIGN OBJECT." }, { "mdr_text_key": "371851965", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE HARMONIC ACE INSTRUMENT WAS NOT RECEIVED FOR FAILURE ANALYSIS INVESTIGATIONS." }, { "mdr_text_key": "381453771", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "381453772", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE HARMONIC ACE INSTRUMENT WAS RECEIVED, AND FAILURE ANALYSIS FOUND THE INSTRUMENT TO HAVE THE CURVED BLADE BROKEN AT THE TIP/MIDPOINT/BASE. A PIECE APPROXIMATELY 0.439\" X 0.085\" WAS FOUND TO BE BROKEN OFF. THE BROKEN PIECE WAS RETURNED. COMPONENTS ADJACENT TO THIS BROKEN BLADE DID NOT SHOW DAMAGE." } ], "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": "08/14/2025" } ] }