{ "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": "2955842-2025-48686", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20251216", "manufacturer_address_2": "", "pma_pmn_number": "K143132", "date_of_event": "20250916", "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": "CH", "manufacturer_contact_area_code": "408", "date_added": "20251216", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20241010", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2050263", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20251216", "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": "L80241010", "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)261031(10)L80241010", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Material Fragmentation", "Material Fragmentation" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "02/24/2026", "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": "4085", "patient": [ { "patient_sequence_number": "1", "date_received": "20251216", "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": "20260318", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "23821831", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20251124", "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": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "396141431", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UPDATED FIELDS: D9, H2, H3, H6, AND H11. DEVICE EVALUATION: INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE HARMONIC ACE INSTRUMENT TO PERFORM FAILURE ANALYSIS. THE INSTRUMENT WAS FOUND TO HAVE ONE BLADES BROKEN AT THE BASE. A PIECE MEASURING APPROXIMATELY 2.0 MM X 10.18 MM IN SIZE WAS FOUND TO BE BROKEN OFF, CONFIRMING THAT A FRAGMENT DETACHED FROM THE INSTRUMENT. THE BROKEN PIECE WAS RETURNED WITH THE INSTRUMENT. COMPONENTS ADJACENT TO THIS BROKEN BLADE DID NOT SHOW DAMAGE." }, { "mdr_text_key": "396141432", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "387811175", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE HARMONIC ACE INSTRUMENT HAS NOT BEEN RECEIVED FOR FAILURE ANALYSIS EVALUATION." }, { "mdr_text_key": "387811176", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LEFT HEMICOLECTOMY PROCEDURE, A FRAGMENT BROKE OFF A HARMONIC ACE INSTRUMENT AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE WHICH WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE HARMONIC ACE INSTRUMENT WAS INSPECTED PRIOR TO USE. THE INSTRUMENT WAS IN USE FOR 16-20 MINUTES PRIOR TO THE EVENT OCCURRING. A PIECE FROM A BLADE ON THE INSTRUMENT WAS FOUND TO BE COMPLETELY DETACHED. AT THAT TIME, THE SURGEON WAS PERFORMING DISSECTION. NO ISSUES WERE NOTED WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE AND BEFORE THE EVENT OCCURRED. THERE WERE ALSO NO INSTRUMENT COLLISIONS." } ], "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": "03/18/2026" } ] }