{
  "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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  "results": [
    {
      "manufacturer_contact_zip_ext": "",
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      "report_to_fda": "N",
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      "manufacturer_contact_address_1": "",
      "manufacturer_contact_pcity": "",
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      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL",
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      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "GM",
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      "date_added": "20210715",
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          "date_removed_flag": "",
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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",
          "manufacturer_d_state": "",
          "manufacturer_d_zip_code": "34000",
          "manufacturer_d_zip_code_ext": "",
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          "udi_public": "",
          "openfda": {
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        "Patient Data Problem"
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      "mfr_report_type": "",
      "manufacturer_contact_country": "",
      "date_changed": "20250811",
      "health_professional": "",
      "summary_report_flag": "N",
      "manufacturer_g1_zip_code_ext": "",
      "manufacturer_contact_extension": "",
      "manufacturer_city": "",
      "manufacturer_contact_phone_number": "",
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          "date_received": "20210715",
          "sequence_number_treatment": [
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          "patient_race": "",
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            "No Clinical Signs, Symptoms or Conditions"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20210827",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "12172027",
      "removal_correction_number": "N/A",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20210618",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
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      ],
      "manufacturer_g1_zip_code": "",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "",
      "adverse_event_flag": "Y",
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      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "325859515",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "DHR REVIEW AND REVIEW OF COMPLAINT HISTORY DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. A FULL ANALYSIS OF THE LOGS AND OF THE PATIENT FOLDER HAS BEEN PERFORMED. THIS ANALYSIS CONCLUDED THAT THE IMPOSSIBILITY TO LOAD THE DICOM FROM THE PACS IS DUE TO A SOFTWARE ISSUE THAT IMPLIES THAT IT IS IMPOSSIBLE TO LOAD A SECOND EXAM WITH THE PACS AFTER HAVING DELETED THE TEMPORARY FOLDER FOR THE SECOND TIME. IT IS RELATED TO A WINDOWS ERROR. THIS ISSUE WILL BE ADDRESSED THROUGH THE CONTINUOUS IMPROVEMENT PROCESS OF OUR PRODUCTS."
        },
        {
          "mdr_text_key": "325859516",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "THE SURGEON SENT A SCREENSHOT, THAT HE COULD NOT LOAD A CT FROM PACS. THE SURGERY WAS PERFORMED CONVENTIONALLY (WITHOUT THE USE OF THE ROBOT), BECAUSE IT WAS NOT POSSIBLE TO LOAD IMAGES."
        },
        {
          "mdr_text_key": "261652177",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "UDI# : (B)(4). THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION IS PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED."
        },
        {
          "mdr_text_key": "261652178",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "THE SURGEON SENT A SCREENSHOT, THAT HE COULD NOT LOAD A CT FROM PACS. THE SURGERY WAS PERFORMED CONVENTIONALLY (WITHOUT THE USE OF THE ROBOT), BECAUSE IT WAS NOT POSSIBLE TO LOAD IMAGES."
        }
      ],
      "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": "08/27/2021"
    }
  ]
}