{ "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": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "N", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "3009185973-2020-00249", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20201006", "manufacturer_address_2": "", "pma_pmn_number": "K200511", "date_of_event": "20200929", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20201006", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1104295", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20201006", "brand_name": "ROSA ONE", "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": "", "manufacturer_d_country": "FR", "manufacturer_d_postal_code": "34000", "device_operator": "HEALTH PROFESSIONAL", "model_number": "ROSA ONE", "catalog_number": "ROSAS00203", "lot_number": "3.1.4.1650", "other_id_number": "", "device_availability": "Yes", "device_report_product_code": "HAW", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Neurological Stereotaxic Instrument", "medical_specialty_description": "Neurology", "regulation_number": "882.4560", "device_class": "2" } } ], "product_problems": [ "Application Program Freezes or Fails to Launch", "Application Program Freezes or Fails to Launch" ], "reporter_state_code": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "10/21/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250805", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20201006", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Code Available", "No Code Available" ] } ], "distributor_city": "", "date_report": "20201023", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10635438", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20200929", "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": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "214543996", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION IS PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. UNIQUE IDENTIFIER (UDI) #: (B)(4)." }, { "mdr_text_key": "214543997", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IN AN ATTEMPT TO REGISTER THE PATIENT, CONTACT-LESS REGISTRATION FAILED MULTIPLE TIMES IN MANY ATTEMPTS TO TROUBLESHOOT ANY ISSUES OCCURRING IN THE OPERATING ROOM. THE FIRST ATTEMPT OF CONTACT-LESS REGISTRATION GAVE AN \"INSUFFICIENT ACCURACY\" ERROR. AT THIS TIME, THE SCANNING OF THE PATIENT WAS ATTEMPTED AGAIN AND THE ERROR WAS NOT SHOWN HOWEVER, THERE WAS SIGNIFICANT ERROR SEEN UPON VERIFICATION. IT WAS DECIDED TO ATTEMPT REGISTRATION FROM THE BEGINNING AGAIN. THIS TIME, THE ERROR ON THE MARKING OF THE POINTS WAS BELOW 1.5 AND MADE SURE THAT NO OR LIGHTS WERE IN THE WAY, NO HAIR ETC. ONCE AGAIN UPON THE COMPLETION OF REGISTRATION, THE \"INSUFFICIENT ACCURACY\" ERROR WAS SEEN. AT THIS TIME, IT WAS DECIDED TO USE A DIFFERENT CT SCAN FOR THE REGISTRATION OF THE PATIENT. THIS DID NOT WORK EITHER AS \"INSUFFICIENT ACCURACY\" ERROR WAS SEEN ONCE MORE. AT THIS TIME, ANOTHER LASER WAS USED AS BS18978 IS IN THE SAME BUILDING. AFTER A FULL RE-BOOT AND USING THE OTHER LASER, THE \"INSUFFICIENT ACCURACY\" ERROR WAS STILL SEEN. AT THIS TIME, THE SURGEONS DECIDED TO EDIT THE PLAN TO ACCOUNT FOR THE ERROR IN THE REGISTRATION AS THIS CAUSED OVER A 2 HOUR DELAY WHILE THE PATIENT WAS UNDER ANESTHESIA. THIS IS A HIGH VOLUME SITE THAT HAS NOT SEEN THIS ISSUE BEFORE." }, { "mdr_text_key": "321329606", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IN AN ATTEMPT TO REGISTER THE PATIENT, CONTACT-LESS REGISTRATION FAILED MULTIPLE TIMES IN MANY ATTEMPTS TO TROUBLESHOOT ANY ISSUES OCCURRING IN THE OPERATING ROOM. THE FIRST ATTEMPT OF CONTACT-LESS REGISTRATION GAVE AN \"INSUFFICIENT ACCURACY\" ERROR. AT THIS TIME, THE SCANNING OF THE PATIENT WAS ATTEMPTED AGAIN AND THE ERROR WAS NOT SHOWN HOWEVER, THERE WAS SIGNIFICANT ERROR SEEN UPON VERIFICATION. IT WAS DECIDED TO ATTEMPT REGISTRATION FROM THE BEGINNING AGAIN. THIS TIME, THE ERROR ON THE MARKING OF THE POINTS WAS BELOW 1.5 AND MADE SURE THAT NO OR LIGHTS WERE IN THE WAY, NO HAIR ETC. ONCE AGAIN UPON THE COMPLETION OF REGISTRATION, THE \"INSUFFICIENT ACCURACY\" ERROR WAS SEEN. AT THIS TIME, IT WAS DECIDED TO USE A DIFFERENT CT SCAN FOR THE REGISTRATION OF THE PATIENT. THIS DID NOT WORK EITHER AS \"INSUFFICIENT ACCURACY\" ERROR WAS SEEN ONCE MORE. AT THIS TIME, ANOTHER LASER WAS USED AS BS18978 IS IN THE SAME BUILDING. AFTER A FULL RE-BOOT AND USING THE OTHER LASER, THE \"INSUFFICIENT ACCURACY\" ERROR WAS STILL SEEN. AT THIS TIME, THE SURGEONS DECIDED TO EDIT THE PLAN TO ACCOUNT FOR THE ERROR IN THE REGISTRATION AS THIS CAUSED OVER A 2 HOUR DELAY WHILE THE PATIENT WAS UNDER ANESTHESIA. THIS IS A HIGH VOLUME SITE THAT HAS NOT SEEN THIS ISSUE BEFORE." }, { "mdr_text_key": "321329607", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A FULL ANALYSIS OF THE LOGS AND OF THE PATIENT FOLDER HAS BEEN PERFORMED. THIS ANALYSIS LED TO THE FOLLOWING OBSERVATIONS : THE WORKFLOW PERFORMED BY THE USER DID NOT REVEAL ANY ISSUES THAT COULD HAVE CAUSED THE INACCURACIES OBSERVED IN THE REGISTRATION PROCESS. THE ORIGIN OF THE REPORTED EVENT REMAINS UNKNOWN. THE MAIN HYPOTHESIS THAT MIGHT EXPLAIN THE REPORTED REGISTRATION INACCURACY WOULD BE THAT THE PATIENT'S ANATOMY - AS REFLECTED IN THE CT SCAN USED - DID NOT MATCH ACCURATELY ENOUGH THE ANATOMICAL LANDMARKS MEASURED THROUGH THE LASER DISTANCE SENSOR DURING THE REGISTRATION PROCESS. INDEED, THE PATIENT'S SKIN TENDS TO CHANGE EASILY AND CAN THEREFORE EXHIBIT A DIFFERENT SURFACE DEPENDING ON THE PATIENT'S POSITION. IF THE SKIN SURFACE HAS CHANGED BETWEEN THE TIME THE CT SCAN IMAGING USED AS A REFERENCE EXAM FOR THE REGISTRATION WAS TAKEN AND THE TIME THE LASER SCAN OF THE PATIENT'S HEAD WAS PERFORMED DURING THE REGISTRATION, AN ERROR MESSAGE WILL BE DISPLAYED. NOTE THAT THIS EFFECT CAN ALSO BE REINFORCED WHEN THE PATIENT IS OVERWEIGHT. IN SUCH CASE, THE USE OF BONE FIDUCIALS MIGHT BE RECOMMENDED TO PERFORM THE REGISTRATION (BECAUSE THEY ARE FIXED TO THE PATIENT'S SKULL, BONE FIDUCIALS AVOID ANY SKIN RELATED ISSUES). BASED ON THE INVESTIGATION PERFORMED, THE TECHNICAL ROOT CAUSE OF THE EVENT REMAINS UNKNOWN. CORRECTED DATA: B4 DATE OF THIS REPORT; G4 DATE RECEIVED BY MANUFACTURER; H2 IF FOLLOW-UP, WHAT TYPE; H3 DEVICE EVALUATED BY MANUFACTURER; H6 EVENT PROBLEM AND EVALUATION CODES; H10 ADDITIONAL NARRATIVES/DATA." } ], "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": "10/23/2020" } ] }