{
  "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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      "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": "2955842-2025-46186",
      "type_of_report": [
        "Initial submission",
        "Followup"
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      "product_problem_flag": "N",
      "date_received": "20251126",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K191736",
      "date_of_event": "20251030",
      "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",
        "Foreign"
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "95051",
      "manufacturer_g1_state": "CA",
      "reporter_country_code": "UK",
      "manufacturer_contact_area_code": "408",
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      "manufacturer_contact_f_name": "IZABEL",
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        {
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          "date_removed_flag": "",
          "device_sequence_number": "2049177",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20251126",
          "brand_name": "DA VINCI",
          "generic_name": "ENDOSCOPE PLUS",
          "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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          "catalog_number": "470057",
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          "device_availability": "Device was returned to manufacturer",
          "device_report_product_code": "GCJ",
          "device_age_text": "DA",
          "device_evaluated_by_manufacturer": "Y",
          "combination_product_flag": "N",
          "udi_di": "00886874116555",
          "udi_public": "(01)00886874116555",
          "openfda": {
            "device_name": "Laparoscope, General & Plastic Surgery",
            "medical_specialty_description": "Gastroenterology, Urology",
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        "Device Reprocessing Problem"
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      "reporter_state_code": "",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "12/08/2025",
      "mfr_report_type": "Follow-Up",
      "manufacturer_contact_country": "US",
      "date_changed": "20260127",
      "health_professional": "",
      "summary_report_flag": "N",
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      "manufacturer_contact_extension": "",
      "manufacturer_city": "",
      "manufacturer_contact_phone_number": "4085",
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        {
          "patient_sequence_number": "1",
          "date_received": "20251126",
          "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": [
            "Unspecified Tissue Injury",
            "Unspecified Tissue Injury"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20260105",
      "initial_report_to_fda": "No",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "SANTA CLARA",
      "mdr_report_key": "23662350",
      "removal_correction_number": "N/A",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20251030",
      "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": "N",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "391375344",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "UPDATED FIELDS: D9, H2, H3, H6, AND H11. DEVICE EVALUATION: INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE 30 DEGREE ENDOSCOPE PLUS TO PERFORM FAILURE ANALYSIS. THE ENDOSCOPE WAS PLACED THROUGH FRICTION TEST USING A SCREENING AID TO MANUALLY ROTATE THE ADAPTER TO ENDOSCOPE HOUSING, THE HOUSING SHELL EXHIBITED LASER MARKING FADING AND/OR REMOVED. THE ENDOSCOPE CABLE INTEGRATED CONNECTOR WAS VISUALLY INSPECTED AND FOUND WITH DAMAGE. THE CABLE INTEGRATED CONNECTOR EXHIBITED CORROSION ON THE ELECTRICAL CONTACTS AND/OR CIRCUIT BOARD."
        },
        {
          "mdr_text_key": "391375345",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION."
        },
        {
          "mdr_text_key": "386256687",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "THE ENDOSCOPE INSTRUMENT HAS NOT BEEN RECEIVED FOR FAILURE ANALYSIS EVALUATION."
        },
        {
          "mdr_text_key": "386256688",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, RUSTING FOUND ON INTERNAL COGS. THE PROCEDURE WAS CONVERTED TO OPEN. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UPS ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT."
        }
      ],
      "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": "01/05/2026"
    }
  ]
}