{ "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": "3009185973-2020-00020", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200205", "manufacturer_address_2": "", "pma_pmn_number": "K182417", "date_of_event": "20200107", "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": "137175", "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": "HEALTH PROFESSIONAL", "model_number": "ROSA ONE", "catalog_number": "N/A", "lot_number": "3.1.0.1276", "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": "FL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "04/16/2020", "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": "20200205", "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": "20200421", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "9669706", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20200107", "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": "316880732", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DHR REVIEW AND REVIEW OF COMPLAINT HISTORY WERE NOT PERFORMED BASED ON THE LOW SEVERITY OF THIS COMPLAINT. A DETAILED ANALYSIS OF THE SOFTWARE LOGS WAS PERFORMED AND SHOWED THAT THE FIRST DEVICE SHUTDOWN OCCURRED WHEN THE SPEED OF THE COOPERATIVE MODE WAS CHANGED MOST LIKELY DUE TO A CRASH OF EITHER THE OPERATING SYSTEM OR THE APPLICATION. HOWEVER, NOT ENOUGH EVIDENCES ARE PROVIDED TO DETERMINE WHICH WAS THE ROOT CAUSE OF THE UNEXPECTED DEVICE SHUTDOWN. THEN, A FIRST UNRECOVERABLE ERROR OCCURRED WHEN THE ROBOT ARM WAS DRIVEN ONTO A PLANNED TRAJECTORY DUE TO A COLLISION OF THE ROBOT ARM WITH THE TELESCOPIC ARM. THIS ISSUE COULD HAVE BEEN AVOIDED BY RELEASING THE FOOT PEDAL, AS EXPLAINED IN THE USER MANUAL THEREFORE, THE ISSUE CAN BE CONSIDERED AS A USE ERROR. SIX OTHERS UNRECOVERABLE FAILURES WERE DETECTED, AT THE ROBOT ARM CONNECTION, DUE TO THE PREVIOUS ROBOT ARM COLLISION. INDEED, THE JOINT J6 WAS STILL IN CONTACT WITH THE TELESCOPIC ARM AND WHEN THE CONTROLLER CHECKED PRESSURE APPLIED ON EACH JOINT, A DEFAULT SITUATION WAS DETECTED ON THE TWO AXIS INVOLVED IN PREVIOUS COLLISION. THIS EVENT CAUSED THE SHUTDOWN OF THE DEVICE WHICH IS A NORMAL BEHAVIOR. FURTHERMORE, ACCORDING TO THE COMPLAINT DESCRIPTION, JOINT J3 WAS MANUALLY MOVED, USING THE BRAKE RELEASE BUTTON, AND AFTER REBOOTING THE DEVICE, THE SURGERY CONTINUED WITH NO MORE ISSUE." }, { "mdr_text_key": "316880733", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "AT THE BEGINNING OF REGISTRATION SURGEON ASKED FOR HIS SPEED TO BE SWITCHED FROM SLOW TO FAST. WHEN USING THE TOUCH SCREEN TO DO THIS TASK, THE SCREEN FROZE AND THE ROBOT SHUTDOWN. WE THEN CONTINUED TO COMPLETE REGISTRATION. AFTER REGISTRATION, THE SURGEON REQUESTED THAT WE USE THE DISTANCE SENSOR TO MARK THE ENTRY POINTS ON THE HEAD. WHILE DRIVING TO TRAJECTORY 13, JOINT NUMBER 6 COLLIDED WITH THE TELESCOPIC ARM. THIS RESULTED IN A SHUTDOWN. AFTER REBOOTING, IT WAS NOT POSSIBLE TO MOVE THE ARM AWAY FROM THE TELESCOPIC ARM BECAUSE THE ROBOT WOULD SHUTDOWN JUST BEFORE SHOWING THE 'CLEARING THE PATIENT' SCREEN. THERE WERE MULTIPLE SHUTDOWNS BEFORE THE FIELD SERVICE ENGINEER (FSE) DECIDED TO MANUALLY RELEASE THE ARM. THE FSE REMOVED THE SIDE PANEL AND MANUALLY RELEASED THE ARM BY MOVING JOINT NUMBER 3. THE FSE REBOOTED THE ROBOT AND CONTINUED ON WITH THE SURGERY. THERE WAS NO HARM TO THE PATIENT. THIS PROCESS DELAYED THE CASE ABOUT 30 MINUTES." }, { "mdr_text_key": "177831750", "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": "177831751", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AT THE BEGINNING OF REGISTRATION SURGEON ASKED FOR HIS SPEED TO BE SWITCHED FROM SLOW TO FAST. WHEN USING THE TOUCH SCREEN TO DO THIS TASK, THE SCREEN FROZE AND THE ROBOT SHUTDOWN. WE THEN CONTINUED TO COMPLETE REGISTRATION. AFTER REGISTRATION, THE SURGEON REQUESTED THAT WE USE THE DISTANCE SENSOR TO MARK THE ENTRY POINTS ON THE HEAD. WHILE DRIVING TO TRAJECTORY 13, JOINT NUMBER 6 COLLIDED WITH THE TELESCOPIC ARM. THIS RESULTED IN A SHUTDOWN. AFTER REBOOTING, IT WAS NOT POSSIBLE TO MOVE THE ARM AWAY FROM THE TELESCOPIC ARM BECAUSE THE ROBOT WOULD SHUTDOWN JUST BEFORE SHOWING THE \"CLEARING THE PATIENT\" SCREEN. THERE WERE MULTIPLE SHUTDOWNS BEFORE THE FIELD SERVICE ENGINEER (FSE) DECIDED TO MANUALLY RELEASE THE ARM. THE FSE REMOVED THE SIDE PANEL AND MANUALLY RELEASED THE ARM BY MOVING JOINT NUMBER 3. THE FSE REBOOTED THE ROBOT AND CONTINUED ON WITH THE SURGERY. THERE WAS NO HARM TO THE PATIENT. THIS PROCESS DELAYED THE CASE ABOUT 30 MINUTES." } ], "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": "04/21/2020" } ] }