{
  "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,
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    {
      "manufacturer_contact_zip_ext": "",
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      "event_location": "",
      "report_to_fda": "",
      "manufacturer_contact_t_name": "",
      "manufacturer_contact_state": "",
      "manufacturer_link_flag": "N",
      "manufacturer_contact_address_2": "",
      "manufacturer_g1_city": "",
      "manufacturer_contact_address_1": "",
      "manufacturer_contact_pcity": "",
      "event_type": "Injury",
      "report_number": "MW5032655",
      "type_of_report": [
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      "product_problem_flag": "Y",
      "date_received": "20131105",
      "manufacturer_address_2": "",
      "pma_pmn_number": "",
      "date_of_event": "20131023",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "RISK MANAGER",
      "manufacturer_contact_plocal": "",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "",
      "source_type": [
        ""
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "",
      "date_added": "20131114",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "569507",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20131105",
          "brand_name": "DA VINCI PERMANENT CAUTERY SPATULA",
          "generic_name": "CAUTERY SPATULA 8MM",
          "manufacturer_d_name": "INTUITIVE SURGICAL, INC.",
          "manufacturer_d_address_1": "",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "SUNNYVALE",
          "manufacturer_d_state": "CA",
          "manufacturer_d_zip_code": "",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "US",
          "manufacturer_d_postal_code": "",
          "device_operator": "HEALTH PROFESSIONAL",
          "model_number": "420184",
          "catalog_number": "",
          "lot_number": "S10090605313",
          "other_id_number": "",
          "device_availability": "Yes",
          "device_report_product_code": "NAY",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "System, Surgical, Computer Controlled Instrument",
            "medical_specialty_description": "Gastroenterology, Urology",
            "regulation_number": "876.1500",
            "device_class": "2"
          }
        }
      ],
      "product_problems": [
        "Material Fragmentation"
      ],
      "reporter_state_code": "FL",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "",
      "manufacturer_contact_country": "",
      "date_changed": "20250819",
      "health_professional": "",
      "summary_report_flag": "N",
      "manufacturer_g1_zip_code_ext": "",
      "manufacturer_contact_extension": "",
      "manufacturer_city": "",
      "manufacturer_contact_phone_number": "",
      "patient": [
        {
          "patient_sequence_number": "1",
          "date_received": "20131105",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            "Required Intervention"
          ],
          "patient_age": "41 YR",
          "patient_sex": "",
          "patient_weight": "66",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Tissue Damage"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20131105",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "3466274",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "manufacturer_name": "",
      "report_source_code": "Voluntary report",
      "remedial_action": [
        ""
      ],
      "manufacturer_g1_zip_code": "",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "",
      "adverse_event_flag": "N",
      "distributor_address_1": "",
      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "3735128",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "THE PT WAS UNDERGOING ROBOTIC MYOMECTOMY AND RIGHT PARATUBAL CYSTECTOMIES USING THE DA-VINCI ROBOT. DURING ENUCLEATION OF ONE OF THE FIBROIDS, WHILE USING THE MONOPOLAR SPATULA, THE PULLEY SYSTEM FOR THE SPATULA BROKE. THE INSTRUMENT WAS REMOVED AND INSPECTED. IT WAS NOTED THAT 2 PIECES WERE MISSING: ONE PIECE WAS THE CIRCULAR GUARD WHICH COVERED THE WIRE PULLEY ON THE SIDE OF THE INSTRUMENT AND THE SECOND WAS THE OVERLYING FLANK WHICH COVERED THE CIRCULAR GUARD. THE SURGEON RETURNED TO THE SURGICAL SITE AND THE CIRCULAR GUARD WAS RECOVERED FROM THE PT. HOWEVER, THE FLANK PIECE COULD NOT BE LOCATED. AFTER EXHAUSTIVE EFFORTS TO LOCATE THE RETAINED PIECE AND DISCUSSION WITH THE PT'S FAMILY, IT WAS AGREED TO ALLOW THE PIECE TO REMAIN IN PLACE WITHOUT PROGRESSING TO MORE INVASIVE EFFORTS TO LOCATE THE PIECE."
        }
      ],
      "number_patients_in_event": "",
      "distributor_name": "",
      "manufacturer_g1_address_1": "",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "",
      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}