{ "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": "2955842-2023-18897", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20231002", "manufacturer_address_2": "", "pma_pmn_number": "K143132", "date_of_event": "20230904", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "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": "", "manufacturer_g1_state": "CA", "reporter_country_code": "KS", "manufacturer_contact_area_code": "408", "date_added": "20231002", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20221110", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1971532", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20231002", "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": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "480275-08", "catalog_number": "480275", "lot_number": "L10221114 0122", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20230918", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "10886874112738", "udi_public": "(01)10886874112738(17)241130(10)L10221114", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Detachment of Device or Device Component", "Detachment of Device or Device Component" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250806", "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": "20231002", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Foreign Body In Patient", "Foreign Body In Patient" ] } ], "distributor_city": "", "date_report": "20230904", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "17852112", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20230904", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "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": "324699307", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE HARMONIC ACE INSTRUMENT AND PERFORMED FAILURE ANALYSIS. THE HARMONIC ACE INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN BLADE. THE BLADE BROKE AT ROUGHLY 0.495¿ FROM THE BASE. THE BROKEN PIECE WAS RETURNED." }, { "mdr_text_key": "324699308", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED THYROIDECTOMY SURGICAL PROCEDURE, THE TIP OF THE HARMONIC ACE INSTRUMENT WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH A BACKUP INSTRUMENT OF THE SAME KIND. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO DAMAGE OBSERVED. DURING THE PROCEDURE, THE INSTRUMENT TIP BROKE OFF AND FELL INSIDE THE PATIENT'S CAVITY AFTER USING IT FOR 15 MINUTES. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE AND CONFIRMED WITH A VISUAL INSPECTION. ADDITIONAL SURGICAL PROCEDURES AND POST-OPERATIVE TESTS WERE NOT PERFORMED. ADDITIONALLY, THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIALS DURING THE SURGICAL PROCEDURE. THE INSTRUMENT WAS NOT REMOVED DURING THE PROCEDURE (PRIOR TO THE BREAKAGE). UPON FINAL REMOVAL OF THE INSTRUMENT, THE WRIST WAS STRAIGHTENED, AND THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. BOTH THE INSTRUMENT AND CANNULA HAD NO OTHER DAMAGE AFTER THE EVENT OCCURRED. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS. NO KNOWN PATIENT CONSEQUENCE WAS REPORTED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }