{
  "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,
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  },
  "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": "2955842-2024-17226",
      "type_of_report": [
        "Initial submission",
        "Followup"
      ],
      "product_problem_flag": "Y",
      "date_received": "20240723",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K143132",
      "date_of_event": "20240621",
      "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": "408",
      "date_added": "20240723",
      "manufacturer_contact_f_name": "IZABEL",
      "device_date_of_manufacturer": "20230623",
      "previous_use_code": "I",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "2480655",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20240723",
          "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": "480275-08",
          "catalog_number": "480275",
          "lot_number": "L81230623",
          "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)250630(10)L81230623",
          "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": "08/01/2024",
      "mfr_report_type": "Follow-Up",
      "manufacturer_contact_country": "US",
      "date_changed": "20250724",
      "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": "20240723",
          "sequence_number_treatment": [
            "DA VINCI INSTRUMENTS AND ACCESSORIES."
          ],
          "sequence_number_outcome": [
            "Required Intervention"
          ],
          "patient_age": "NA",
          "patient_sex": "Prefer Not To Disclose",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Foreign Body In Patient",
            "Foreign Body In Patient"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20240628",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "SANTA CLARA",
      "mdr_report_key": "19808920",
      "removal_correction_number": "N/A",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20240628",
      "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": "350877941",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION."
        },
        {
          "mdr_text_key": "350877942",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "THE HARMONIC ACE CURVED SHEARS INSTRUMENT HAS BEEN RECEIVED FOR FAILURE ANALYSIS EVALUATION. THE INSTRUMENT WAS FOUND TO HAVE ONE BLADE BROKEN AT THE BASE AND A PIECE MEASURING 0.461\" X 0.084\" WAS BROKEN OFF. THE BROKEN PIECE WAS NOT RETURNED."
        },
        {
          "mdr_text_key": "347512098",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE HARMONIC ACE INSTRUMENT INVOLVED WITH THE REPORTED EVENT FOR FAILURE ANALYSIS EVALUATION. THEREFORE, THE CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED."
        },
        {
          "mdr_text_key": "347512099",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, WHILE USING THE HARMONIC ACE INSTRUMENT, THE BLADE OF THE INSTRUMENT BROKE OFF AND FELL INSIDE THE PATIENT. THE BLADE WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH A BACKUP HARMONIC ACE INSTRUMENT."
        }
      ],
      "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": "08/28/2024"
    }
  ]
}