{
  "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": "2955842-2025-33677",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "Y",
      "date_received": "20250813",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K182371",
      "date_of_event": "20250722",
      "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",
        "Company representation"
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "95051",
      "manufacturer_g1_state": "CA",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "408",
      "date_added": "20250813",
      "manufacturer_contact_f_name": "IZABEL",
      "device_date_of_manufacturer": "20240809",
      "previous_use_code": "R",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "2585789",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20250813",
          "brand_name": "DA VINCI SP",
          "generic_name": "PATIENT SIDE CART",
          "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": "380601-51",
          "catalog_number": "380601",
          "lot_number": "N/A",
          "other_id_number": "",
          "device_availability": "No",
          "device_report_product_code": "NAY",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "N",
          "combination_product_flag": "N",
          "udi_di": "00886874114605",
          "udi_public": "(01)00886874114605",
          "openfda": {
            "device_name": "System, Surgical, Computer Controlled Instrument",
            "medical_specialty_description": "Gastroenterology, Urology",
            "regulation_number": "876.1500",
            "device_class": "2"
          }
        }
      ],
      "product_problems": [
        "Break",
        "Break"
      ],
      "reporter_state_code": "CA",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Initial",
      "manufacturer_contact_country": "US",
      "date_changed": "20250926",
      "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": "20250813",
          "sequence_number_treatment": [
            "DA VINCI INSTRUMENTS AND ACCESSORIES"
          ],
          "sequence_number_outcome": [
            "Other"
          ],
          "patient_age": "NA",
          "patient_sex": "Unknown",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Insufficient Information",
            "Insufficient Information"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20250722",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "SANTA CLARA",
      "mdr_report_key": "22800346",
      "removal_correction_number": "N/A",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20250722",
      "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": "N",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "377604564",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. NOTE: A DA VINCI SP PATIENT SIDE CART WAS ENTERED DUE TO INSUFFICIENT INFORMATION PROVIDED REGARDING THE GRASPER INSTRUMENT INVOLVED WITH THE REPORTED EVENT. THE INSTRUMENT NAME, PART #, LOT #, AND UDI # ARE UNKNOWN."
        },
        {
          "mdr_text_key": "377604565",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "IT WAS REPORTED THAT DURING AN UNSPECIFIED DA VINCI-ASSISTED SURGICAL PROCEDURE, THE JAW OF A GRASPER INSTRUMENT BROKE. THE CUSTOMER WANTED TO KNOW IF THE GRASPER INSTRUMENT WAS RADIOPAQUE. IT IS UNCLEAR WHEN THE DEVICE ISSUE WAS IDENTIFIED. THE FOLLOWING INFORMATION IS UNKNOWN: THE PROCEDURE NAME, THE SPECIFIC INSTRUMENT NAME, THE INSTRUMENT'S PART AND LOT #S, WHAT SURGICAL TASK WAS BEING PERFORMED WHEN THE INSTRUMENT BROKE, IF A FRAGMENT BROKE OFF THE INSTRUMENT AND FELL INSIDE THE PATIENT, IF THERE WAS ANY INJURY TO THE PATIENT, AND THE PROCEDURE OUTCOME."
        }
      ],
      "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": ""
    }
  ]
}