{ "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": "N", "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": "2955842-2026-04885", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "", "date_received": "20260223", "manufacturer_address_2": "", "pma_pmn_number": "K143132", "date_of_event": "20260130", "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", "Foreign" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "KS", "manufacturer_contact_area_code": "", "date_added": "20260223", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20251106", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "618898", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260223", "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": "480275-12", "catalog_number": "480275", "lot_number": "K11251106 0012", "other_id_number": "", "device_availability": "", "device_report_product_code": "NAY", "device_age_text": "DAY", "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": [ "Detachment of Device or Device Component" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/18/2026", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20260814", "health_professional": "N", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20260223", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20260609", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "24413860", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20260129", "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": "", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "15967369215", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DEVICE EVALUATION:INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE HARMONIC ACE INSTRUMENT TO PERFORM FAILURE ANALYSIS. THE INSTRUMENT WAS FOUND TO HAVE BLADES BROKEN AT THE BASE. A PIECE MEASURING APPROXIMATELY 16.31 MM X 2.14 MM IN SIZE WAS FOUND TO BE BROKEN OFF, CONFIRMING THAT A FRAGMENT DETACHED FROM THE INSTRUMENT. THE BROKEN PIECE WAS NOT RETURNED." }, { "mdr_text_key": "393650755", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE THE HARMONIC ACE INSTRUMENT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS." }, { "mdr_text_key": "393650756", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A FRAGMENT FELL INTO THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. NO ABNORMALITIES WERE OBSERVED DURING THE PRE-OPERATIVE INSPECTION OF THE INSTRUMENT. THE PROBLEM WAS IDENTIFIED DURING GRASPING, WHICH IS WHEN THE BREAKAGE OCCURRED, AND THERE WERE NO COLLISIONS WITH OTHER INSTRUMENTS AT ANY POINT DURING USE. THE AFFECTED AREAS INCLUDED THE OPENING AND CLOSING OF THE GRIP, ITS LATERAL MOVEMENT, AND THE UP AND DOWN MOVEMENT OF THE WRIST. FRAGMENTS FELL INTO THE PATIENT AND WERE SUBSEQUENTLY RETRIEVED USING LAPAROSCOPIC TOOLS. NO X-RAY WAS PERFORMED. THE INSTRUMENT HAD BEEN IN USE FOR 60 MINUTES PRIOR TO THE ONSET OF THE ISSUE, WHICH WAS DISCOVERED INTRAOPERATIVELY. INCREASED PRESSURE ON THE BLADE WAS SUSPECTED TO BE THE CAUSE OF THE PROBLEM, LEADING TO TIP BREAKAGE WHILE REMOVING THE INSTRUMENT; THE TIP WAS THEN IMMEDIATELY REMOVED. AT THE TIME OF REMOVAL, THE WRIST WAS EXTENDED, NO RESISTANCE WAS FELT THROUGH THE CANNULA, AND THERE WERE NO VISIBLE SIGNS OF DAMAGE TO THE CANNULA OR OTHER INSTRUMENT PARTS. THE PROCEDURE WAS COMPLETED." }, { "mdr_text_key": "15467369214", "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": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "06/09/2026" } ] }