{
  "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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      "date_added": "20211119",
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          "generic_name": "SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT",
          "manufacturer_d_name": "INTUITIVE SURGICAL, INC.",
          "manufacturer_d_address_1": "",
          "manufacturer_d_address_2": "",
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          "manufacturer_d_state": "CA",
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          "manufacturer_d_country": "US",
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          "catalog_number": "471405",
          "lot_number": "N11210603 0025",
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          "openfda": {
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            "medical_specialty_description": "Gastroenterology, Urology",
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      "date_changed": "20250808",
      "health_professional": "Y",
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      "patient": [
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          "date_received": "20211117",
          "sequence_number_treatment": [
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          "patient_sex": "Female",
          "patient_weight": "91 KG",
          "patient_ethnicity": "Non Hispanic",
          "patient_race": "White",
          "patient_problems": [
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            "No Clinical Signs, Symptoms or Conditions"
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      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "12835694",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "manufacturer_name": "",
      "report_source_code": "Voluntary report",
      "remedial_action": [
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      "report_to_manufacturer": "",
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      "mdr_text": [
        {
          "mdr_text_key": "281080045",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "A ROBOTIC FORCE BIPOLAR INSTRUMENT WAS USED DURING THE CASE. \"A SPRING?\" BROKE DURING THE CASE. AT FIRST IT WAS UNKNOWN IF ANY FRAGMENTS FELL OFF INTO THE PATIENT. AN X-RAY WAS ORDERED AND TAKEN. NO DENSITIES WERE SEEN ON THE X-RAY. A NEW INSTRUMENT WAS OPENED AND THE CASE WAS COMPLETED. THIS INSTRUMENT WILL BE SENT BACK TO INTUITIVE FOR EVALUATION AND REIMBURSEMENT; 3/12 LIVES REMAIN ON INSTRUMENT. THERE ARE NO APPARENT MISSING SCREWS NOR BROKEN CABLES UPON VISUAL INSPECTION, HOWEVER THE JAWS OF THE INSTRUMENT AREN'T ABLE TO BE OPENED ALL THE WAY. FDA SAFETY REPORT ID # (B)(4)."
        }
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      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
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}