{ "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": "2955842-2025-47852", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20251210", "manufacturer_address_2": "", "pma_pmn_number": "K143132", "date_of_event": "20251103", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "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": "CI", "manufacturer_contact_area_code": "408", "date_added": "20251210", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20250730", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1085302", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20251210", "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": "K10250730 0376", "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)280731(10)K10250730", "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": "03/02/2026", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20260317", "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": "20251210", "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": "20260304", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "23770666", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20251113", "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": "387298499", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL CYSTECTOMY PROCEDURE, A PIECE FROM ONE OF THE JAWS OF THE HARMONIC ACE INSTRUMENT BROKE OFF AND FELL INSIDE THE PATIENT. THE DEVICE FRAGMENT FELL INSIDE THE PATIENT WHILE THE SURGEON GRIPPING TISSUE AND AS THE DOCTOR WAS TAKING A TISSUE SAMPLE. THE FRAGMENT WAS RETRIEVED USING TWEEZERS AND IT WAS CONFIRMED VISUALLY THAT ALL FRAGMENTS WERE REMOVED. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED FOR FRAGMENT REMOVAL, AND NO POST-OPERATIVE TESTS SUCH AS X-RAYS OR ULTRASOUNDS WERE PERFORMED. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITHOUT ANY INJURY TO THE PATIENT. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO ANY POST-SURGICAL COMPLICATIONS." }, { "mdr_text_key": "387298500", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AN INTUITIVE SURGICAL, INC. (ISI) PRODUCT HAS NOT BEEN RECEIVED FOR FAILURE ANALYSIS EVALUATION. A REVIEW OF AN IMAGE PROVIDED BY THE CUSTOMER SHOWS A BROKEN CURVED BLADE ON THE HARMONIC ACE INSTRUMENT. A MARYLAND BIPOLAR FORCEPS INSTRUMENT IS HOLDING THE BROKEN BLADE PIECE." }, { "mdr_text_key": "395738564", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "395738565", "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 FOUND TO HAVE THE BLADE BROKEN AT THE BASE. A PIECE APPROXIMATELY 0.412\" X 0.073\" WAS FOUND TO BE BROKEN OFF. THE BROKEN PIECE WAS NOT RETURNED WITH THE INSTRUMENT. COMPONENTS ADJACENT TO THIS BROKEN BLADE DID NOT SHOW DAMAGE." } ], "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": "03/04/2026" } ] }