{ "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": "2955842-2025-34974", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20250825", "manufacturer_address_2": "", "pma_pmn_number": "K143132", "date_of_event": "20250728", "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": "20250825", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20240725", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2243429", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250825", "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": "L82240725 0142", "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": "", "udi_public": "", "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": "09/22/2025", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20251201", "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": "20250825", "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": "20250731", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "22889753", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250731", "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": "384688250", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE HARMONIC ACE INSTRUMENT WAS ANALYZED AND FOUND TO HAVE THE CURVED BLADE BROKEN AT THE TIP OF THE BLADE. A PIECE APPROXIMATELY 0.444\" X 0.085\" 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 FOUND TO FAIL THE ENERGY RECOGNITION TEST. THE INSTRUMENT WAS PLACED ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT WAS CONNECTED TO AN IN-HOUSE ENERGY GENERATOR. A TORQUE WRENCH WAS USED TO TIGHTEN THE ASSEMBLY UNTIL IT WAS AS TIGHT AS IT COULD BE. THE INSTRUMENT FAILED THE ENERGY RECOGNITION TEST." }, { "mdr_text_key": "384688251", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "378513251", "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 SHOWS A CURVED BLADE OF A HARMONIC ACE INSTRUMENT THAT IS BROKEN." }, { "mdr_text_key": "378513252", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PANCREATICODUODENECTOMY PROCEDURE, THE CUSTOMER RECEIVED A \"REDUCE TIP PRESSURE\" MESSAGE WHILE USING THE HARMONIC ACE INSTRUMENT. THE NURSE TOOK OUT THE INSTRUMENT, AND AT THAT TIME, THE HARMONIC ACE INSTRUMENT WAS INTACT. THEN THE NURSE WIPED ADHERED TISSUE AT THE TIP OF THE HARMONIC ACE INSTRUMENT WITH GAUZE AND THEN INSERTED THE INSTRUMENT INTO THE ROBOTIC ARM. THE CHIEF SURGEON THEN INSPECTED THE HARMONIC ACE INSTRUMENT. THE CUSTOMER OBSERVED THAT THE TIP OF THE HARMONIC ACE INSTRUMENT BROKE. A FRAGMENT FELL INSIDE THE PATIENT BUT WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE WHICH WAS COMPLETED WITH A BACKUP HARMONIC ACE INSTRUMENT." } ], "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": "10/16/2025" } ] }