{
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    "terms": "https://open.fda.gov/terms/",
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    "last_updated": "2026-09-08",
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      "date_of_event": "20140918",
      "reprocessed_and_reused_flag": "",
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          "brand_name": "ROSA SURGICAL DEVICE",
          "generic_name": "COMPUTER ASSISTED SURGICAL DEVICE",
          "manufacturer_d_name": "MEDTECH SA",
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          "openfda": {
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      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "",
      "date_changed": "20250815",
      "health_professional": "",
      "summary_report_flag": "N",
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      "patient": [
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          "date_received": "20150115",
          "sequence_number_treatment": [
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          "patient_age": "27 YR",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
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      "date_report": "20150115",
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      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "4495483",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20141217",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
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      ],
      "manufacturer_g1_zip_code": "",
      "report_to_manufacturer": "",
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      "adverse_event_flag": "Y",
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      "manufacturer_state": "",
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      "single_use_flag": "",
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      "mdr_text": [
        {
          "mdr_text_key": "15318263",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "ON (B)(6) 2014, ROSA DEVICE HAS BEEN USED TO GUIDE THE IMPLANTATION OF 13 DEPTH ELECTRODES FOR A CRANIAL SEEG. ON (B)(6) 2014, USER IN NEUROLOGY DEPARTMENT SENT US A LETTER ABOUT AN INCIDENT OCCURRED ON (B)(6) 2014 FOLLOWING THE SURGERY. THE INCIDENT WAS A SUBDURAL BLEEDING ON A (B)(6) MALE PT."
        },
        {
          "mdr_text_key": "15764596",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "A MEDTECH DEVICE ENGINEER PERFORMED QC/PERFORMANCE VERIFICATION TESTING WITH THE ROSA ROBOTIC SYSTEM AT THE HOSPITAL TO FURTHER INVESTIGATE CUSTOMER COMPLAINT. NO INACCURACY WAS FOUND AND SYSTEM WAS FOUND FULLY FUNCTIONAL. CUSTOMER HEAD FRAME WAS ALSO TESTED AND FOUND. FUNCTIONAL. NO FURTHER ACTION WILL BE TAKEN. INVESTIGATION IS CLOSED."
        }
      ],
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      "distributor_name": "",
      "manufacturer_g1_address_1": "",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "",
      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}