{ "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": "2955842-2025-29782", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20250717", "manufacturer_address_2": "", "pma_pmn_number": "K143132", "date_of_event": "20250612", "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": "CH", "manufacturer_contact_area_code": "408", "date_added": "20250717", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20240604", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "752684", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250717", "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": "L81240604", "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)260630(10)L81240604", "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": "07/18/2025", "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": "20250717", "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": "20250626", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "22538124", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250626", "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": "381427458", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "381427459", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UPDATED FIELDS: D9, H2, H3, H6, AND H11. ADDITIONAL INFORMATION: THE HARMONIC ACE INSTRUMENT WAS INSPECTED PRIOR TO USE. WHEN THE EVENT OCCURRED, THE SURGEON WAS PERFORMING DISSECTION AND THE INSTRUMENT WAS IN USE FOR ABOUT 10 MINUTES. THERE WERE NO ISSUES NOTED WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE. ACCORDING TO THE CUSTOMER, THE FRAGMENT FELL INSIDE OF THE PATIENT DURING AN INSTRUMENT/ACCESSORY COLLISION. THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. THERE WAS NO DAMAGE TO THE CANNULA AFTER THE EVENT OCCURRED. THE CUSTOMER USED A LAPAROSCOPIC INSTRUMENT TO REMOVE THE FRAGMENT. AN X-RAY WAS PERFORMED AND THE SURGEON CONFIRMED THAT NO FRAGMENTS WERE LEFT BEHIND. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENT. THE PROCEDURE WAS COMPLETED ROBOTICALLY. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS. THERE ARE NO IMAGES OF DEVICES OR A VIDEO RECORDING AVAILABLE FOR REVIEW. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE HARMONIC ACE INSTRUMENT TO PERFORM FAILURE ANALYSIS. THE INSTRUMENT WAS ANALYZED AND FOUND TO HAVE ONE BLADES BROKEN AT THE BASE. A PIECE MEASURING APPROXIMATELY 0.084\" X 0.437\" IN SIZE WAS FOUND TO BE BROKEN OFF. THE BROKEN PIECE WAS NOT RETURNED. COMPONENTS ADJACENT TO THIS BROKEN BLADE DID NOT SHOW DAMAGE. ADDITIONALLY, THE INSTRUMENT WAS CONNECTED TO AN IN-HOUSE ENERGY GENERATOR. THE INSTRUMENT FAILED THE ENERGY RECOGNITION TEST. THE INSTRUMENT GENERATED \"REPLACE INSTRUMENT\" MESSAGE ." }, { "mdr_text_key": "375237362", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE HARMONIC ACE INSTRUMENT HAS NOT BEEN RECEIVED FOR FAILURE ANALYSIS EVALUATION. A REVIEW OF AN IMAGE PROVIDED BY THE CUSTOMER WAS PERFORMED. THE INSTRUMENT DID NOT APPEAR TO SHOW A MISSING PIECE." }, { "mdr_text_key": "375237363", "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 HARMONIC ACE INSTRUMENT AND A RECOGNITION ISSUE AND THE TINES COULD NOT BE MOVED. MOREOVER, A WHITE PAD FROM THE HARMONIC ACE INSTRUMENT FELL INSIDE THE PATIENT'S BODY BUT WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE. A BACKUP HARMONIC ACE INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE ROBOTICALLY." } ], "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": "08/09/2025" } ] }