{ "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": "2955842-2025-41245", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20251009", "manufacturer_address_2": "", "pma_pmn_number": "K143132", "date_of_event": "20250814", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "PHYSICIAN", "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": "20251009", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20241107", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2177474", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20251009", "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": "L11241107 0360", "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": [ "Output Problem", "Output Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "11/04/2025", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20260123", "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": "20251009", "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": [ "Unspecified Tissue Injury", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20251201", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "23262644", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250914", "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": "382179974", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE HARMONIC ACE INSTRUMENT HAS NOT BEEN RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR FAILURE ANALYSIS. A REVIEW OF AN IMAGE PROVIDED BY THE CUSTOMER APPEARS TO SHOW A HARMONIC ACE INSTRUMENT WITH NO VISIBLE DAMAGE. THE CAUSE OF THE CUSTOMER REPORTED ISSUE CANNOT BE CONFIRMED WITHOUT THE RETURNED DEVICE." }, { "mdr_text_key": "382179975", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE CUSTOMER EXPERIENCED UNSTABLE ENERGY OUTPUT WITH A HARMONIC ACE INSTRUMENT. AS A RESULT, THE CUSTOMER ELECTED TO CONVERT THE CASE TO TRADITIONAL LAPAROSCOPIC SURGERY AND AN ADDITIONAL INCISION WAS PLACED." }, { "mdr_text_key": "390088831", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "TWO HARMONIC ACE INSTRUMENTS WERE RETURNED THAT WERE USED DURING THE SAME PROCEDURE. THE FIRST ONE WAS RECEIVED FOR FAILURE ANALYSIS. VISUAL INSPECTION DISPLAYED NO SIGNS OF PHYSICAL DAMAGE. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION. THE BLADE OPENED AND CLOSED PROPERLY. 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 (CLICKING SOUNDS). THE INSTRUMENT PASSED THE ENERGY RECOGNITION TEST. THE INSTRUMENT WAS FULLY FUNCTIONAL. THERE WAS NO PROBLEM DETECTED. THE SECOND HARMONIC ACE INSTRUMENT RECEIVED, VISUAL INSPECTION DISPLAYED NO SIGNS OF PHYSICAL DAMAGE. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION. THE BLADE OPENED AND CLOSED PROPERLY. 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 (CLICKING SOUNDS). THE INSTRUMENT PASSED THE ENERGY RECOGNITION TEST. THE INSTRUMENT WAS FULLY FUNCTIONAL. THERE WAS NO PROBLEM DETECTED." }, { "mdr_text_key": "390088832", "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": "12/01/2025" } ] }