{ "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": "3009185973-2018-00253", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20181002", "manufacturer_address_2": "", "pma_pmn_number": "PK101791", "date_of_event": "20180821", "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": [ "DISTRIBUTOR" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "CH", "manufacturer_contact_area_code": "", "date_added": "20181002", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "766678", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20181002", "brand_name": "ROSA SURGICAL DEVICE", "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 2.5.8", "catalog_number": "N/A", "lot_number": "2.5.8.4", "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", "Computer Software Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "10/31/2018", "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": "20181002", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Known Impact Or Consequence To Patient", "No Known Impact Or Consequence To Patient" ] } ], "distributor_city": "", "date_report": "20181108", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "7926204", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20180910", "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": "122336558", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION WILL BE PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED." }, { "mdr_text_key": "122336559", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "A ROSA TECHNICIAN WORKING FOR THE (B)(6) DISTRIBUTOR INFORMED A FIELD SERVICE ENGINEER BY EMAIL ON SEPTEMBER 10TH 2018 THAT THE SURGICAL TEAM HAD A COUPLE OF REBOOTS DURING THE LAST MONTHS. LOG FILES WERE SENT FOR THE PERIOD (B)(6) TO (B)(6) 2018 AND WERE ANALYZED. ONE OCCURENCE HAS BEEN FOUND ON (B)(6). LOG FILES SHOW THAT 3 SOFTWARE CRASHES AND ONE COMMUNICATION ERROR OCCURRED DURING A SURGERY." }, { "mdr_text_key": "310462911", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT THE DEVICE ENCOUNTERED MULTIPLE CRASHES DURING A SURGERY. DHR REVIEW AND REVIEW OF COMPLAINT HISTORY DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. ACCORDING TO TECHNICAL INVESTIGATION FOUR EVENTS OCCURRED DURING THE SURGERY. THE ROOT CAUSE OF THE FIRST DEVICE SHUTDOWN CANNOT BE DETERMINED. THE ROOT CAUSE OF THE SECOND DEVICE SHUTDOWN IS A COMPUTER SHUTDOWN OR TO A COMPUTER CRASH. THE ROOT CAUSE OF THE THIRD SHUTDOWN IS A SIMULTANEOUS CRASH OF ROSANNA AND ROSARIO SOFTWARE. THE ROOT CAUSE OF THE LAST EVENT IS A SHARED MEMORY PROBLEM BETWEEN ROSARIO AND THE CONTROLLER. CORRECTED DATA: DATE OF THIS REPORT. DATE RECEIVED BY MANUFACTURER (DATE OF THE COMPLETION OF THE INVESTIGATION). IF FOLLOW-UP, WHAT TYPE. DEVICE EVALUATED BY MANUFACTURER. EVALUATION CODE (METHOD, RESULTS AND CONCLUSION)." }, { "mdr_text_key": "310462912", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A ROSA TECHNICIAN WORKING FOR THE CHINESE DISTRIBUTOR INFORMED A FIELD SERVICE ENGINEER BY EMAIL ON SEPTEMBER 10TH 2018 THAT THE SURGICAL TEAM HAD A COUPLE OF REBOOTS DURING THE LAST MONTHS. LOG FILES WERE SENT FOR THE PERIOD JANUARY TO AUGUST 2018 AND WERE ANALYZED. ONE OCCURENCE HAS BEEN FOUND ON AUGUST 21TH. LOG FILES SHOW THAT 3 SOFTWARE CRASHES AND ONE COMMUNICATION ERROR OCCURRED DURING A SURGERY." } ], "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": "11/09/2018" } ] }