{
  "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",
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      "manufacturer_g1_city": "SANTA CLARA",
      "manufacturer_contact_address_1": "3410 CENTRAL EXPRESSWAY",
      "manufacturer_contact_pcity": "40852321",
      "event_type": "Injury",
      "report_number": "2955842-2026-21430",
      "type_of_report": [
        "Initial submission"
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      "manufacturer_address_2": "",
      "pma_pmn_number": "K181395",
      "date_of_event": "20260316",
      "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": [
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      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "95051",
      "manufacturer_g1_state": "CA",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "",
      "date_added": "20260414",
      "manufacturer_contact_f_name": "IZABEL",
      "device_date_of_manufacturer": "20260114",
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        {
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          "device_sequence_number": "931264",
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          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20260414",
          "brand_name": "DA VINCI",
          "generic_name": "SEAL",
          "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",
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          "manufacturer_d_country": "US",
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          "device_availability": "Device was returned to manufacturer",
          "date_returned_to_manufacturer": "20260409",
          "device_report_product_code": "GCJ",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "Y",
          "combination_product_flag": "N",
          "udi_di": "10886874116408",
          "udi_public": "(01)10886874116408(10)K10260114",
          "openfda": {
            "device_name": "Laparoscope, General & Plastic Surgery",
            "medical_specialty_description": "Gastroenterology, Urology",
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        }
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        "Material Fragmentation"
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      "reporter_state_code": "NC",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Initial",
      "manufacturer_contact_country": "US",
      "date_changed": "20260416",
      "health_professional": "",
      "summary_report_flag": "N",
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      "manufacturer_contact_extension": "",
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      "manufacturer_contact_phone_number": "",
      "patient": [
        {
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          "date_received": "20260414",
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            "DA VINCI INSTRUMENTS AND ACCESSORIES"
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          "sequence_number_outcome": [
            "Required Intervention"
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          "patient_age": "NA",
          "patient_sex": "Unknown",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Foreign Body In Patient"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20260414",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "SANTA CLARA",
      "mdr_report_key": "24873029",
      "removal_correction_number": "N/A",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20260320",
      "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": "398330138",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION PROCEDURE, THE RUBBER COMPONENT OF THE UNIVERSAL SEAL BROKE AND A FRAGMENT FELL INTO THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING A DIFFERENT PROCEDURE. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO FURTHER DETAILS WERE AVAILABLE REGARDING THE REPORTED EVENT."
        },
        {
          "mdr_text_key": "398330139",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE UNIVERSAL SEAL ACCESSORY FOR EVALUATION. FAILURE ANALYSIS IDENTIFIED A TEAR IN THE BLACK RUBBER DUCKBILL SEAL. NOT ALL TORN PIECES WERE RETURNED WITH THE SEAL."
        }
      ],
      "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": ""
    }
  ]
}