{ "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": "3009185973-2019-00234", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20190715", "manufacturer_address_2": "", "pma_pmn_number": "K172444", "date_of_event": "20190617", "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": "20190715", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "585629", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190715", "brand_name": "ROSA BRAIN", "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 BRAIN", "catalog_number": "N/A", "lot_number": "3.0.0.21", "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": "PA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "01/10/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250815", "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": "20190715", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient", "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200127", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8788266", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20190617", "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": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "316968615", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DEVICE HISTORY RECORD REVIEW AND COMPLAINT HISTORY REVIEW DID NOT IDENTIFY CONTRIBUTING FACTORS. AN ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED. THIS ANALYSIS CONCLUDED THAT A FIRST COMMUNICATION ISSUE OCCURRED IN GUIDANCE DUE TO A VIGILANCE DEVICE FAILURE. THIS TYPE OF ERROR CAN BE PROVOKED BY A MOMENTARY BREAKDOWN OF THE FOOT PEDAL OR, MOST LIKELY, BY AN INCORRECT USAGE OF THE FOOT PEDAL. NOT ENOUGH ELEMENTS ARE PROVIDED TO DETERMINE WITH CERTAINTY WHICH WAS AT THE ORIGIN OF THE DEVICE SHUTDOWN. A SECOND COMMUNICATION ISSUE OCCURRED IN GUIDANCE DUE TO AN OVER FORCE DETECTED BY THE CONTROLLER. THIS EVENT CAN BE PROVOKED EITHER BY A COLLISION OF THE ROBOT ARM WITH AN ELEMENT NEARBY OR BY A CABLE PINCH PREVENTING THE ROBOT ARM TO FINISH FREELY ITS MOVE. THE ROOT CAUSE FOR THIS ISSUE CANNOT BE DETERMINED WITH CERTAINTY, LOG FILES AND COMPLAINT DESCRIPTION DID NOT PROVIDE ENOUGH ELEMENTS. THEN, ANOTHER COMMUNICATION FAILURE WAS DETECTED, AT THE ARM CONNECTION, DUE TO THE PREVIOUS OVER FORCE. THE ROBOT ARM WAS LIKELY STILL IN CONTACT WITH THE OBSTACLE OR THE CABLE WAS STILL PINCHED, THAT IS WHY THE CONTROLLER DETECTED A DEFAULT SITUATION ON THE AXIS PREVIOUSLY INVOLVED CAUSING ITS SHUTDOWN. THIS EVENT CAUSED THE SHUTDOWN OF THE DEVICE WHICH IS A NORMAL BEHAVIOR. A FOURTH COMMUNICATION WITH THE ROBOT ARM FAILURE OCCURRED DURING THE ACCESSIBILITY CHECKS OF A TRAJECTORY AFTER MODIFYING THE FINAL TOOL ORIENTATION, DUE TO A KNOWN SOFTWARE ANOMALY." }, { "mdr_text_key": "316968616", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT THERE WERE TWO COMMUNICATION FAILURES DURING THE SURGERY. ONE UNEXPECTED COMMUNICATION FAILURE WHEN THE ROBOT ARM HAD NAVIGATED TO 13TH TRAJECTORY. IMAGES TAKEN OF ARM IN POSITION. 12 OTHER ELECTRODE TRAJECTORIES HAD BEEN COMPLETED WITHOUT ISSUE. DELAY OF 3 MINUTES. LATER ON, ROBOT ARM SENT TO HOME TO ADJUST ANGLE OF APPROACH TO AVOID MAYFIELD. UPON CHANGE OF TRAJECTORY, ROBOT ARM WAS IN HOME POSITION. UNEXPECTEDLY SHUTDOWN WITH ERROR 'COMMUNICATION FAILURE'. ADJUSTED ANGLE OF TRAJECTORY. ROUGHLY 10 MINUTE DELAY. NAVIGATED TO PREVIOUS BOLT TO CONFIRM CORRECT POSITION OF PATIENT AND MAINTENANCE OF REGISTRATION." }, { "mdr_text_key": "151021082", "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": "151021083", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT THERE WERE TWO COMMUNICATION FAILURES DURING THE SURGERY. ONE UNEXPECTED COMMUNICATION FAILURE WHEN ROBOT ARM HAD NAVIGATED TO 13TH TRAJECTORY. IMAGES TAKEN OF ARM IN POSITION. 12 OTHER ELECTRODE TRAJECTORIES HAD BEEN COMPLETED WITHOUT ISSUE. DELAY OF 3 MINUTES. LATER ON, ROBOT ARM SENT TO HOME TO ADJUST ANGLE OF APPROACH TO AVOID MAYFIELD. UPON CHANGE OF TRAJECTORY, ROBOT ARM WAS IN HOME POSITION. UNEXPECTEDLY SHUTDOWN WITH ERROR \" COMMUNICATION FAILURE\". ADJUSTED ANGLE OF TRAJECTORY. ROUGHLY 10 MINUTE DELAY. NAVIGATED TO PREVIOUS BOLT TO CONFIRM CORRECT POSITION OF PATIENT AND MAINTENANCE OF REGISTRATION." } ], "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": "01/27/2020" } ] }