{ "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": "3009185973-2020-00058", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200220", "manufacturer_address_2": "", "pma_pmn_number": "K182417", "date_of_event": "20200122", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "BIOMEDICAL ENGINEER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "FR", "manufacturer_contact_area_code": "", "date_added": "20200220", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "195470", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200220", "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": "0", "model_number": "ROSA ONE", "catalog_number": "ROSAS00201", "lot_number": "3.1.1.1295", "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": [ "Computer Software Problem", "Connection Problem", "Computer Software Problem", "Connection Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "11/24/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250801", "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": "20200220", "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": "20201125", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "9731346", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20200122", "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": "321548989", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ANALYSIS OF AVAILABLE INFORMATION REVEALED THAT THE REPORTED ISSUES (LANGUAGE AND PACS) WERE DUE TO CONFIGURATION ERRORS PROBABLY INTRODUCED BY THE OPERATOR DURING THE SOFTWARE UPGRADE PERFORMED ON THE DAY BEFORE THE EVENT. THE TECHNICAL ROOT CAUSE OF THE EVENT WAS DETERMINED TO BE AN OPERATOR ERROR. THE REPORTED ISSUES WERE FIXED ON THE EVENT DAY." }, { "mdr_text_key": "321548990", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ON (B)(6) 2020, A FIELD SERVICE ENGINEER (FSE) WAS PRESENT TO ASSIST A SURGERY AFTER THE UPGRADE OF DEVICE (B)(6) FROM 3.0 TO 3.1 BY A TECHNICAL TEAM MEMBER THE DAY BEFORE. AT THE BEGINNING, TWO PROBLEMS WERE IDENTIFIED, THE SOFTWARE LANGUAGE WAS NOT FRENCH AND THE DIRECT TRANSFER CONNECTION BETWEEN THE DEVICE AND THE O-ARM WAS NOT ESTABLISHED. THE FSE CALLED TWO OTHER FSES IN ORDER TO FIX THE ISSUE. AFTER MODIFICATION, THE DEVICE STAYED BLOCKED 1 HOUR WITHOUT BEING ABLE TO BE STARTED FOLLOWING THE MODIFICATION OF THE IP ADDRESS OF THE PACS. THE FSE CALLED A SERVICE TRANSFER ENGINEER IN ORDER TO OBTAIN THE CORRECT IP ADDRESS AND FIX THE ISSUE. SURGERY WAS PERFORMED NORMALLY WITH ONE HOUR DELAY." }, { "mdr_text_key": "189882636", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "(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": "189882637", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON 22-JAN-2020, A FIELD SERVICE ENGINEER (FSE) WAS PRESENT TO ASSIST A SURGERY AFTER THE UPGRADE OF DEVICE BS16928 FROM 3.0 TO 3.1 BY A TECHNICAL TEAM MEMBER THE DAY BEFORE. AT THE BEGINNING, TWO PROBLEMS WERE IDENTIFIED, THE SOFTWARE LANGUAGE WAS NOT FRENCH AND THE DIRECT TRANSFER CONNECTION BETWEEN THE DEVICE AND THE O-ARM WAS NOT ESTABLISHED. THE FSE CALLED TWO OTHER FSES IN ORDER TO FIX THE ISSUE. AFTER MODIFICATION, THE DEVICE STAYED BLOCKED 1 HOUR WITHOUT BEING ABLE TO BE STARTED FOLLOWING THE MODIFICATION OF THE IP ADDRESS OF THE PACS. THE FSE CALLED A SERVICE TRANSFER ENGINEER IN ORDER TO OBTAIN THE CORRECT IP ADDRESS AND FIX THE ISSUE. SURGERY WAS PERFORMED NORMALLY WITH ONE HOUR DELAY." } ], "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": "11/25/2020" } ] }