{
  "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": {
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    {
      "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": "2955842-2024-16690",
      "type_of_report": [
        "Initial submission",
        "Followup"
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      "product_problem_flag": "Y",
      "date_received": "20240710",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K081137",
      "date_of_event": "20240611",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "95051",
      "reporter_occupation_code": "NURSE",
      "manufacturer_contact_plocal": "4085232100",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "NIELSON",
      "source_type": [
        "Other",
        "Foreign",
        "Health Professional"
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      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "95051",
      "manufacturer_g1_state": "CA",
      "reporter_country_code": "CH",
      "manufacturer_contact_area_code": "408",
      "date_added": "20240710",
      "manufacturer_contact_f_name": "IZABEL",
      "previous_use_code": "R",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "2142615",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20240710",
          "brand_name": "DA VINCI",
          "generic_name": "ENERGY ACTIVATION CABLE, ETHICON",
          "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",
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          "model_number": "371870-05",
          "catalog_number": "371870",
          "lot_number": "N/A",
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          "device_availability": "Device was returned to manufacturer",
          "date_returned_to_manufacturer": "20240709",
          "device_report_product_code": "NAY",
          "device_age_text": "DA",
          "device_evaluated_by_manufacturer": "Y",
          "combination_product_flag": "N",
          "udi_di": "00886874110393",
          "udi_public": "(01)00886874110393",
          "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": [
        "Energy Output Problem",
        "Energy Output Problem"
      ],
      "reporter_state_code": "",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "07/10/2024",
      "mfr_report_type": "Initial",
      "manufacturer_contact_country": "US",
      "date_changed": "20250731",
      "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": "20240710",
          "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": [
            "Unspecified Tissue Injury",
            "Unspecified Tissue Injury"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20240611",
      "initial_report_to_fda": "No",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "SANTA CLARA",
      "mdr_report_key": "19712963",
      "removal_correction_number": "N/A",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20240611",
      "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": "346590398",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE PRODUCT FOR EVALUATION, BUT THE FAILURE ANALYSIS INVESTIGATIONS HAVE NOT BEEN COMPLETED."
        },
        {
          "mdr_text_key": "346590399",
          "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 ENERGY CABLE WAS UNABLE TO TRANSMIT ENERGY. THE USER CONVERTED TO OPEN SURGERY WITH A PROCEDURE DELAY GREATER THAN 30 MINUTES. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT."
        },
        {
          "mdr_text_key": "349233826",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "THE ETHICON CABLE ACCESSORY HAS BEEN RETURNED AND EVALUATED BY THE FAILURE ANALYSIS TEAM. THE REPORTED ISSUE WITH THE INSTRUMENT COULD NOT BE REPLICATED NOR CONFIRMED. VISUAL INSPECTION DISPLAYED NO SIGNS OF PHYSICAL DAMAGE TO THE CABLE. THE CABLE COULD NOT BE TESTED FOR ENERGY TRANSMISSION DUE TO NO FIXTURE AVAILABILITY. NO PRODUCT ISSUE WAS IDENTIFIED."
        },
        {
          "mdr_text_key": "349233827",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION."
        }
      ],
      "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": "08/06/2024"
    }
  ]
}