{
  "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",
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    {
      "manufacturer_contact_zip_ext": "",
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      "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": "2955842-2024-13705",
      "type_of_report": [
        "Initial submission"
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      "product_problem_flag": "Y",
      "date_received": "20240423",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K143132",
      "date_of_event": "20240306",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "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": "",
      "manufacturer_g1_state": "CA",
      "reporter_country_code": "CH",
      "manufacturer_contact_area_code": "408",
      "date_added": "20240423",
      "manufacturer_contact_f_name": "IZABEL",
      "device_date_of_manufacturer": "20230427",
      "previous_use_code": "I",
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        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "1381861",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20240423",
          "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": "",
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          "device_operator": "HEALTH PROFESSIONAL",
          "model_number": "480275-08",
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          "lot_number": "L81230427 0103",
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          "device_availability": "Device was returned to manufacturer",
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          "device_report_product_code": "NAY",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "Y",
          "combination_product_flag": "N",
          "udi_di": "10886874112738",
          "udi_public": "(01)10886874112738(10)L81230427",
          "openfda": {
            "device_name": "System, Surgical, Computer Controlled Instrument",
            "medical_specialty_description": "Gastroenterology, Urology",
            "regulation_number": "876.1500",
            "device_class": "2"
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        }
      ],
      "product_problems": [
        "Break",
        "Break"
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      "reporter_state_code": "",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Initial",
      "manufacturer_contact_country": "",
      "date_changed": "20250730",
      "health_professional": "",
      "summary_report_flag": "N",
      "manufacturer_g1_zip_code_ext": "",
      "manufacturer_contact_extension": "",
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      "manufacturer_contact_phone_number": "4085",
      "patient": [
        {
          "patient_sequence_number": "1",
          "date_received": "20240423",
          "sequence_number_treatment": [
            "DA VINCI INSTRUMENTS AND ACCESSORIES"
          ],
          "sequence_number_outcome": [
            ""
          ],
          "patient_age": "NA",
          "patient_sex": "Unknown",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Foreign Body In Patient",
            "Foreign Body In Patient"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20240327",
      "initial_report_to_fda": "No",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "SANTA CLARA",
      "mdr_report_key": "19169050",
      "removal_correction_number": "N/A",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20240327",
      "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": "340899894",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INSTRUMENT AND FAILURE ANALYSIS WAS COMPLETED. THE HARMONIC ACE INSTRUMENT WAS FOUND TO HAVE A BROKEN BLADE AT THE MIDPOINT/BASE. A PIECE APPROXIMATELY 0.085\" X 0.532\" WAS FOUND TO BE BROKEN OFF. THE BROKEN PIECE WAS RETURNED. COMPONENTS ADJACENT TO THIS BROKEN BLADE DO NOT SHOW DAMAGE."
        },
        {
          "mdr_text_key": "340899895",
          "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 BLADE OF THE HARMONIC ACE INSTRUMENT FRACTURED AS THE INSTRUMENT WAS ACTIVATED. THE SURGEON CLAIMED THAT HE DID NOT TOUCH ANY HARD OBJECTS WITH THE INSTRUMENT. THE FRACTURED PIECE FELL INSIDE THE PATIENT BUT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED AS PLANNED."
        }
      ],
      "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": ""
    }
  ]
}