{ "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": "2955842-2024-23072", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20241213", "manufacturer_address_2": "", "pma_pmn_number": "K143132", "date_of_event": "20241118", "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" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20241213", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20240613", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1924012", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20241213", "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": "L82240613 0056", "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)L82240613", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "No Device Output", "No Device Output" ], "reporter_state_code": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "12/18/2024", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250822", "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": "20241213", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "74 YR", "patient_sex": "Male", "patient_weight": "69 KG", "patient_ethnicity": "Hispanic", "patient_race": "", "patient_problems": [ "Unspecified Tissue Injury", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20241118", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "20929640", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20241121", "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": "359208215", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE HARMONIC ACE INSTRUMENT FOR FAILURE ANALYSIS EVALUATION. THEREFORE, THE CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED." }, { "mdr_text_key": "359208216", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION PROCEDURE, THE HARMONIC ACE INSTRUMENT WOULD NOT PASS SELF-TESTING. THE SYSTEM LOGS SHOWED NO RELATED ERRORS. THE CUSTOMER EXPLAINED THAT WHILE PERFORMING A GENERATOR SELF-TEST, THERE WAS A PROMPT TO TIGHTEN THE INSTRUMENT. PRIOR TO CALLING AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) FOR ASSISTANCE, THE CUSTOMER REPLACED THE HARMONIC ACE INSTRUMENT WITH NO CHANGE. THE TSE HAD THE CUSTOMER CLOSE THE CLAMP BY TURNING THE INPUT DISC ON THE HOUSING IN A COUNTERCLOCKWISE DIRECTION AND THEN ROTATE THE TORQUE WRENCH IN A CLOCKWISE DIRECTION UNTIL TWO LOUD CLICKS WERE HEARD. THE SELF-TEST THEN PASSED AND THE CUSTOMER WAS ABLE TO USE THE HARMONIC ACE INSTRUMENT. THE TSE RECOMMENDED RETURNING THE PREVIOUS HARMONIC ACE INSTRUMENTS FOR FAILURE ANALYSIS. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER PROCEEDED WITH THE CASE USING MULTIPLE HARMONIC ACE INSTRUMENTS; THE 4TH HARMONIC WAS FUNCTIONAL. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY DUE TO THE LENGTH OF THE PROCEDURE AND NONFUNCTIONAL DEVICES. THE PATIENT TOLERATED THE CHANGE TO OPEN SURGERY. TROUBLESHOOTING WAS PERFORMED WITH ISI TECHNICAL SUPPORT, BUT THE ISSUE WAS NOT RESOLVED. THE SYSTEM WAS INSPECTED PRIOR TO USE BY THE STAFF. TESTING OF THE INSTRUMENTS FAILED DURING SETUP OF THE SYSTEM. THE PROCEDURE HAS BEEN IN PROGRESS FOR ABOUT 10 TO 15 MINUTES WHEN THE ISSUE NOTED. ANESTHESIA HAD ALREADY BEEN ADMINISTERED AND PORTS WERE PLACED AT THE TIME. THERE WERE NO POST OPERATIVE COMPLICATIONS REPORTED." }, { "mdr_text_key": "361944410", "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 FOUND TO HAVE A CRACKED BLADE NEAR THE BASE OF THE BLADE. THE INSTRUMENT WAS INSTALLED ON AN IN-HOUSE GENERATOR WHERE IT FAILED ENERGY RECOGNITION. AN ERROR WAS DISPLAYED \"REPLACE INSTRUMENT.\" THE ACCESSORY BLADE BROKE DURING IN-HOUSE FAILURE ANALYSIS." }, { "mdr_text_key": "361944411", "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": "01/09/2025" } ] }