{
  "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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      "date_added": "20170405",
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          "serviced_by_3rd_party_flag": "",
          "date_received": "20170405",
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          "generic_name": "COMPUTER-ASSISTED SURGICAL DEVICE",
          "manufacturer_d_name": "MEDTECH SA",
          "manufacturer_d_address_1": "ZAC EUREKA",
          "manufacturer_d_address_2": "900 RUE DU MAS DE VERCHANT",
          "manufacturer_d_city": "MONTPELLIER, LANGUEDOC-ROUSSILLON",
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          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Neurological Stereotaxic Instrument",
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        "Device Displays Incorrect Message"
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      "reporter_state_code": "",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "10/20/2016",
      "mfr_report_type": "",
      "manufacturer_contact_country": "",
      "date_changed": "20250804",
      "health_professional": "",
      "summary_report_flag": "N",
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            ""
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          "patient_problems": [
            "No Code Available",
            "No Code Available"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20171005",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "6460460",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20161020",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
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      ],
      "manufacturer_g1_zip_code": "",
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      "manufacturer_g1_name": "",
      "adverse_event_flag": "Y",
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      "manufacturer_state": "",
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      "single_use_flag": "",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "71725517",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "THE DEVICE RO 15 047 HAS BEEN INSPECTED FOR INVESTIGATION PURPOSE. THE TESTS PERFORMED CONFIRMED THAT A SOFTWARE BUG CAUSED THE OBSERVED ISSUE. THE INTERNAL COMPLAINT REFERENCE IS THE FOLLOWING: (B)(4)."
        },
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          "text": "IT HAS BEEN REPORTED THAT DURING A SURGERY, A SOFTWARE FAILURE HAS BEEN DETECTED. INCORRECT AUTOMATIC IMAGE FUSION WITH STEREOTACTIC FRAME WAS REPORTED. A SURGERY DELAY OF 2 HOURS HAS BEEN REPORTED."
        },
        {
          "mdr_text_key": "187135585",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "THE INITIAL REPORTER ADDRESS WAS REPORTED WRONGLY. INITIAL REPORTER NAME AND ADDRESS\". CHANGED TO: (B)(6)."
        }
      ],
      "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": "10/21/2017"
    }
  ]
}