{ "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": "2955842-2025-16731", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20250429", "manufacturer_address_2": "", "pma_pmn_number": "K143132", "date_of_event": "20241219", "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": "20250429", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20240110", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1790423", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250429", "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": "480275-08", "catalog_number": "480275", "lot_number": "L80240110 0341", "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)260131(10)L80240110", "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": "06/23/2025", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250731", "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": "20250429", "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": "20250401", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "21928927", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250401", "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": "369176838", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PANCREATODUODENECTOMY PROCEDURE, THE HARMONIC ACE INSTRUMENT BROKE AND A PIECE FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. A BACK-UP HARMONIC ACE INSTRUMENT WAS THEN USED BUT THE SAME ISSUE OCCURRED. ANOTHER BROKEN PIECE WAS RETRIEVED. A THIRD BACK-UP HARMONIC ACE INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE." }, { "mdr_text_key": "369177265", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE HARMONIC ACE INSTRUMENT HAS NOT BEEN RECEIVED A FOR FAILURE ANALYSIS EVALUATION. A REVIEW OF AN IMAGE PROVIDED BY THE CUSTOMER SHOWS A HARMONIC ACE INSTRUMENT WITH A BROKEN AND SEPARATED CURVED BLADE." }, { "mdr_text_key": "375079024", "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 ONE BLADE BROKEN AT THE BASE. A PIECE APPROXIMATELY 0.3285\" X 0.0870\" WAS FOUND TO BE BROKEN OFF. THE BROKEN PIECE WAS RETURNED. COMPONENTS ADJACENT TO THIS BROKEN BLADE DID NOT SHOW DAMAGE. THE FINDINGS CONFIRMED THE CUSTOMER REPORTED EVENT." }, { "mdr_text_key": "375079025", "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": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/07/2025" } ] }