{
  "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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    {
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      "pma_pmn_number": "K011002",
      "date_of_event": "20110118",
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      "reporter_occupation_code": "RISK MANAGER",
      "manufacturer_contact_plocal": "",
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      "date_added": "20111003",
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      "device": [
        {
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          "date_removed_flag": "",
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          "date_received": "20110805",
          "brand_name": "DA VINCI S SURGICAL SYSTEM",
          "generic_name": "ENDOSCOPIC INSTRUMENT CONTROL SYSTEM",
          "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": "",
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          "device_operator": "HEALTH PROFESSIONAL",
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          "openfda": {
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            "medical_specialty_description": "Gastroenterology, Urology",
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      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "*",
      "mfr_report_type": "FDA Requested",
      "manufacturer_contact_country": "",
      "date_changed": "20250827",
      "health_professional": "",
      "summary_report_flag": "N",
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      "manufacturer_contact_extension": "",
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      "patient": [
        {
          "patient_sequence_number": "1",
          "date_received": "20110805",
          "sequence_number_treatment": [
            "DA VINCI S SYSTEM INSTRUMENTS AND ACCESSORIES"
          ],
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          ],
          "patient_age": "",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
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        }
      ],
      "distributor_city": "",
      "date_report": "20130121",
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      "distributor_state": "",
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      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "2193069",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20110707",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
        ""
      ],
      "manufacturer_g1_zip_code": "",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "",
      "adverse_event_flag": "Y",
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      "manufacturer_state": "",
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      "manufacturer_postal_code": "",
      "single_use_flag": "",
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      "mdr_text": [
        {
          "mdr_text_key": "10489347",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "(B)(4)."
        },
        {
          "mdr_text_key": "9213474",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "ON (B)(4) 2011, (B)(4) HOSPITAL (B)(4), STATED THAT THE PATIENT INJURY WAS NOT BELIEVED TO BE A RESULT OF A DA VINCI S SYSTEM MALFUNCTION. INTUITIVE SURGICAL HAS MADE MULTIPLE ATTEMPTS TO OBTAIN DETAILED INFORMATION CONCERNING THE PATIENT, THEIR DIAGNOSIS, PRE-EXISTING MEDICAL CONDITIONS AND / OR ANY OTHER RELATED ADDITIONAL INFORMATION. HOWEVER, ON (B)(4) 2011, (B)(4), STATED THAT SHE IS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION ABOUT THIS CASE."
        },
        {
          "mdr_text_key": "2131466",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "ON (B)(6) 2011 (B)(4) REPORTED THAT POST A DA VINCI S HYSTERECTOMY PROCEDURE, WHICH TOOK PLACE ON (B)(6) 2011, THE PATIENT RETURNED TO THE HOSPITAL WITH COMPLICATIONS AND WAS FOUND TO HAVE A BOWEL PERFORATION."
        }
      ],
      "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": "01/22/2013"
    }
  ]
}