{ "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": "2955842-2025-41499", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20251015", "manufacturer_address_2": "", "pma_pmn_number": "K143132", "date_of_event": "20250801", "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", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "CH", "manufacturer_contact_area_code": "", "date_added": "20251015", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20251025", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "239371", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20251015", "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": "L80240201 0071", "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": [ "Detachment of Device or Device Component", "Detachment of Device or Device Component" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "10/27/2025;06/26/2026", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20260814", "health_professional": "", "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": "20251015", "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": "20260721", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "23291051", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250915", "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": "388083868", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "388083869", "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 THE CURVED BLADE BROKEN AT THE TIP/MIDPOINT/BASE. A PIECE MEASURING APPROXIMATELY 0.628\" X 0085\" IN SIZE WAS FOUND TO BE BROKEN OFF. THE BROKEN PIECE WAS NOT RETURNED. COMPONENTS ADJACENT TO THIS BROKEN BLADE DO NOT SHOW DAMAGE. ADDITIONAL INFORMATION: THE TIP OF THE INSTRUMENT BROKE AND FELL INSIDE THE PATIENT WHILE THE SURGEON WAS PERFORMING A DISSECTING TASK. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR HARD MATERIALS DURING THE SURGERY. THE SURGEON RETRIEVED THE FRAGMENT USING ANOTHER INSTRUMENT, AND THE CUSTOMER CONFIRMED THAT ALL FRAGMENTS WERE SUCCESSFULLY REMOVED. NO X-RAYS OR OTHER IMAGING WERE USED TO VERIFY REMOVAL, AND NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED. THE PROCEDURE WAS COMPLETED USING BACKUP OF THE SAME TYPE OF INSTRUMENT. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING THE FRAGMENT. ADDITIONALLY, NO PHOTOGRAPHIC IMAGES OF THE DEVICE OR VIDEO RECORDINGS OF THE PROCEDURE ARE AVAILABLE FOR REVIEW." }, { "mdr_text_key": "408169588", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "CORRECTION INFORMATION CAN BE FOUND IN THE FOLLOWING FIELDS: D4 AND H4." }, { "mdr_text_key": "408169589", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "382480285", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE HARMONIC ACE INSTRUMENT INVOLVED IN THIS REPORTED EVENT WAS NOT RECEIVED FOR INVESTIGATIONS." }, { "mdr_text_key": "382480286", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT BROKE AND A FRAGMENT FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE CUSTOMER USED A BACKUP HARMONIC ACE INSTRUMENT TO COMPLETE THE PROCEDURE ROBOTICALLY." } ], "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": "11/20/2025;07/21/2026" } ] }