{
  "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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      "report_to_fda": "",
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      "reprocessed_and_reused_flag": "N",
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      "reporter_country_code": "GM",
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          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20251203",
          "brand_name": "DA VINCI XI",
          "generic_name": "VISION SIDE SYSTEM, RECONDITIONED",
          "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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          "openfda": {
            "device_name": "System, Surgical, Computer Controlled Instrument",
            "medical_specialty_description": "Gastroenterology, Urology",
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        "Energy Output Problem"
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      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Initial",
      "manufacturer_contact_country": "US",
      "date_changed": "20251215",
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      "summary_report_flag": "N",
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      "manufacturer_contact_extension": "",
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          "date_received": "20251203",
          "sequence_number_treatment": [
            "DA VINCI INSTRUMENTS AND ACCESSORIES."
          ],
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          "patient_sex": "Unknown",
          "patient_weight": "",
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          "patient_race": "",
          "patient_problems": [
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            "Unspecified Tissue Injury"
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        }
      ],
      "distributor_city": "",
      "date_report": "20251203",
      "initial_report_to_fda": "No",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "SANTA CLARA",
      "mdr_report_key": "23706428",
      "removal_correction_number": "N/A",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20251105",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
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      ],
      "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": "386639949",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RECTOPEXY PROCEDURE, THE CUSTOMER INDICATED THAT THE ERBE GENERATOR MALFUNCTIONED AND THE SURGEON COULD NO LONGER CUT TISSUE. AS A RESULT, THE SURGEON ELECTED TO CONVERT THE CASE TO OPEN SURGERY. THE SURGEON EXPLAINED THAT THE REASON FOR THE CONVERSION TO OPEN SURGERY WAS THAT ROBOTIC ELECTROCOAGULATION WAS NO LONGER AVAILABLE AND A LAPAROSCOPIC INTRACORPOREAL ANASTOMOSIS WAS NOT A VIABLE OPTION FOR AN EXTENDED ILEOCECAL RESECTION. POST-OPERATIVELY, THE PATIENT EXPERIENCED NO COMPLICATIONS."
        },
        {
          "mdr_text_key": "386639950",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE SYSTEM LOGS AND IDENTIFIED ERRORS WHICH INDICATE THAT EITHER THE FOOT PEDALS OF THE ERBE GENERATOR WERE BLOCKED OR ONE OF THE CABLES AT THE BACK OF THE GENERATOR WAS NOT PROPERLY PLUGGED IN. THE CUSTOMER IDENTIFIED THAT THE CAUSE OF THE ISSUE WAS THAT THE CABLES WERE NOT PLUGGED IN PROPERLY. THE ISSUE WAS RESOLVED."
        }
      ],
      "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": ""
    }
  ]
}