{ "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": "3009185973-2020-00027", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200205", "manufacturer_address_2": "", "pma_pmn_number": "K182417", "date_of_event": "20200114", "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": "20200205", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "134857", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200205", "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": "ROSAS00203", "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", "Computer Software Problem" ], "reporter_state_code": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/30/2020", "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": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200205", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Code Available", "No Code Available" ] } ], "distributor_city": "", "date_report": "20200730", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "9670522", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20200114", "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": "319251687", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A FULL ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED. THIS ANALYSIS CONCLUDED THAT THE ROBOT ARM FAILED TO CONNECT WHEN ATTEMPTING TO LAUNCH THE REGISTRATION. THE ERROR MESSAGE 'UNRECOVERABLE ERROR DETECTED' WAS DISPLAYED AND THE DEVICE SHUTDOWN. ALTHOUGH THE DEVICE WAS REBOOTED MULTIPLE TIMES THEREAFTER, THE ARM STILL FAILED TO CONNECT IN MAINTENANCE SESSION. THE DEVICE WAS ALSO BOOTED EARLIER IN THE DAY AND MULTIPLE CONNECTIONS TO THE SOFTWARE WERE SUPERIMPOSED WITH THE SAME ISSUE OF CONNECTION TO THE ARM, WHICH IS AN ABNORMAL BEHAVIOR. THE ANALYSIS SHOWED THAT THE COMPLAINT IS CONFIRMED. THE ISSUE WAS FIXED ON 17-JAN-2020 DURING A DEVICE MAINTENANCE, AFTER THREE REBOOT ATTEMPTS. HOWEVER, THE ROOT CAUSE FOR THE REPORTED EVENT REMAINS UNDETERMINED. 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." }, { "mdr_text_key": "319251688", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "EVENT REPORTED BY THE FIELD SERVICE ENGINEER : THE ROBOT BS18962, WOULDN¿T CONNECT. THE PATIENT WAS ATTACHED TO THE ROBOT, AS WE WANTED TO START THE REGISTRATION PROCESS THE ROBOT DISPLAYED 'UNRECOVERABLE ERROR OCCURRED' WHICH RESULTED IN A SHUTDOWN. WHEN THE ISSUE OCCURRED WE DISCONNECTED THE PATIENT WITHIN 15-20 MINUTES AND THE SURGERY WAS PERFORMED USING A DIFFERENT METHOD." }, { "mdr_text_key": "177806900", "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. (B)(4)." }, { "mdr_text_key": "177806901", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "EVENT REPORTED BY THE FIELD SERVICE ENGINEER : THE ROBOT BS18962, WOULDN¿T CONNECT. THE PATIENT WAS ATTACHED TO THE ROBOT, AS WE WANTED TO START THE REGISTRATION PROCESS THE ROBOT DISPLAYED 'UNRECOVERABLE ERROR OCCURRED' WHICH RESULTED IN A SHUTDOWN. WHEN THE ISSUE OCCURRED WE DISCONNECTED THE PATIENT WITHIN 15-20 MINUTES AND THE SURGERY WAS PERFORMED USING A DIFFERENT METHOD." } ], "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": "07/30/2020" } ] }