{
  "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": "",
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      "event_location": "",
      "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": "2955842-2025-19358",
      "type_of_report": [
        "Initial submission",
        "Followup"
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      "product_problem_flag": "Y",
      "date_received": "20250509",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K191280",
      "date_of_event": "20250417",
      "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",
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        "Other",
        "Foreign"
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "95051",
      "manufacturer_g1_state": "CA",
      "reporter_country_code": "UK",
      "manufacturer_contact_area_code": "408",
      "date_added": "20250509",
      "manufacturer_contact_f_name": "IZABEL",
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        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "2654114",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20250509",
          "brand_name": "DA VINCI ENERGY",
          "generic_name": "SYNCHROSEAL",
          "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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          "catalog_number": "480440",
          "lot_number": "L12230622",
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          "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": "10886874117306",
          "udi_public": "(01)10886874117306(17)250630(10)L12230622",
          "openfda": {
            "device_name": "System, Surgical, Computer Controlled Instrument",
            "medical_specialty_description": "Gastroenterology, Urology",
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        }
      ],
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        "Detachment of Device or Device Component",
        "Detachment of Device or Device Component"
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      "reporter_state_code": "",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "08/13/2025",
      "mfr_report_type": "Initial",
      "manufacturer_contact_country": "US",
      "date_changed": "20251118",
      "health_professional": "",
      "summary_report_flag": "N",
      "manufacturer_g1_zip_code_ext": "",
      "manufacturer_contact_extension": "",
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      "manufacturer_contact_phone_number": "4085",
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        {
          "patient_sequence_number": "1",
          "date_received": "20250509",
          "sequence_number_treatment": [
            "DA VINCI INSTRUMENTS AND ACCESSORIES"
          ],
          "sequence_number_outcome": [
            "Required Intervention"
          ],
          "patient_age": "NA",
          "patient_sex": "Unknown",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "No Clinical Signs, Symptoms or Conditions",
            "No Clinical Signs, Symptoms or Conditions"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20250417",
      "initial_report_to_fda": "No",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "SANTA CLARA",
      "mdr_report_key": "21996182",
      "removal_correction_number": "N/A",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20250417",
      "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": "369940547",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "THE SYNCHROSEAL INSTRUMENT HAS NOT BEEN RECEIVED FOR FAILURE ANALYSIS EVALUATION."
        },
        {
          "mdr_text_key": "369940548",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY PROCEDURE, THE PLASTIC RING BECAME SEPARATED FROM THE SYNCHROSEAL INSTRUMENT. THE SURGEON NOTICED IT, REMOVED THE PIECE, ENSURED ALL PIECES WERE REMOVED, AND EXCHANGED FOR A NEW INSTRUMENT. THE PROCEDURE WAS COMPLETED."
        },
        {
          "mdr_text_key": "383084849",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "UPDATED FIELDS: D9, H2, H3, H6, AND H11. DEVICE EVALUATION: THE SYNCHROSEAL INSTRUMENT WAS RECEIVED AND FAILURE ANALYSIS FOUND THE INSTRUMENT TO HAVE THE JAW COVER TORN. THE TEARS MEASURED ROUGHLY 0.1190\" X 0.1415\". VISUAL INSPECTION DISPLAYED NO SIGNS OF MISSING FRAGMENTS. THERE ARE NO SIGNS OF THERMAL DAMAGE PRESENT AT THE END OF ANY TEARS."
        },
        {
          "mdr_text_key": "383084850",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "REFER TO 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": "09/02/2025"
    }
  ]
}