{
  "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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      "manufacturer_contact_address_1": "",
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      "type_of_report": [
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      "pma_pmn_number": "K081137",
      "date_of_event": "20120525",
      "reprocessed_and_reused_flag": "N",
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      "date_added": "20120629",
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          "date_removed_flag": "",
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          "brand_name": "DA VINCI SI 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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          "catalog_number": "",
          "lot_number": "",
          "other_id_number": "",
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          "device_report_product_code": "NAY",
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          "combination_product_flag": "N",
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          "openfda": {
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            "medical_specialty_description": "Gastroenterology, Urology",
            "regulation_number": "876.1500",
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      "product_problems": [
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      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "",
      "date_changed": "20250810",
      "health_professional": "",
      "summary_report_flag": "N",
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      "manufacturer_contact_extension": "",
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      "manufacturer_contact_phone_number": "",
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          "patient_sequence_number": "1",
          "date_received": "20120629",
          "sequence_number_treatment": [
            "DA VINCI SI INSTRUMENTS AND ACCESSORIES"
          ],
          "sequence_number_outcome": [
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          "patient_age": "",
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        }
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      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "2634699",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20120529",
      "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",
      "distributor_address_1": "",
      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "",
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      "mdr_text": [
        {
          "mdr_text_key": "2827338",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "IT WAS REPORTED THAT AFTER UNDERGOING A DA VINCI SI CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2012, THE PATIENT LATER EXPIRED ON (B)(6) 2012. DURING THE SURGICAL PROCEDURE, THE SURGEON DECIDED TO REMOVE THE PATIENT'S GALL BLADDER USING TRADITIONAL LAPAROSCOPIC TECHNIQUES AND WITHOUT USING A BAG. AN ISI REPRESENTATIVE IN ATTENDANCE DURING THE SURGICAL PROCEDURE INDICATED THAT NO SYSTEM MALFUNCTIONS OCCURRED DURING THE CASE AND THE PLANNED PROCEDURE WAS COMPLETED WITHOUT ANY ISSUES."
        },
        {
          "mdr_text_key": "10119356",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "DESPITE MULTIPLE REQUESTS, THE SURGEON WHO PERFORMED THE PATIENT'S DA VINCI SURGICAL PROCEDURE HAS NOT PROVIDED INTUITIVE SURGICAL WITH ANY ADDITIONAL INFORMATION REGARDING THIS EVENT. AS STATED, AN ISI REPRESENTATIVE IN ATTENDANCE DURING THE SURGICAL PROCEDURE INDICATED THAT NO SYSTEM MALFUNCTIONS OCCURRED DURING THE CASE AND THE PLANNED PROCEDURE WAS COMPLETED WITHOUT ANY ISSUES. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED."
        }
      ],
      "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": ""
    }
  ]
}