{ "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": "3009185973-2019-00394", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20191114", "manufacturer_address_2": "", "pma_pmn_number": "K172444", "date_of_event": "20191023", "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": "20191114", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1115871", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20191114", "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": "ROSAS00303", "lot_number": "3.0.0.21", "other_id_number": "", "device_availability": "Yes", "device_report_product_code": "HAW", "device_age_text": "", "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": [ "Unintended Collision", "Unintended Collision" ], "reporter_state_code": "PA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250812", "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": "20191114", "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": "20191114", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "9321125", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20191023", "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": "174316306", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "(B)(4). EVENT SUMMARY, DEVICE HISTORY RECORD REVIEW AND COMPLAINT HISTORY REVIEW DID NOT IDENTIFY CONTRIBUTING FACTORS. AN ANALYSIS OF THE DATA LOGS FROM THE SUBJECT SURGERY HAS BEEN PERFORMED. THIS ANALYSIS CONCLUDED THAT THE FIRST COMMUNICATION ERROR WAS DUE TO A COLLISION OF THE ROBOT ARM WITH THE MAYFIELD HEAD HOLDER. THIS ISSUE COULD HAVE BEEN AVOIDED BY RELEASING THE PEDAL, AS EXPLAINED IN THE USER MANUAL THEREFORE, THE ISSUE CAN BE CONSIDERED AS A USE ERROR. THE TWO FOLLOWING COMMUNICATION FAILURES WERE DUE TO THE PREVIOUS COLLISION AS THE ARM WAS LIKELY STILL IN CONTACT WITH THE MAYFIELD. THE LAST DETECTED COMMUNICATION ERROR WAS DUE TO A CONTROLLER ERROR. THIS ISSUE OCCURRED AT THE ARM CONNECTION AND IT MOST LIKELY HAPPENED BECAUSE THE ROBOT ARM WAS STILL IN CONTACT WITH THE MAYFIELD. HOWEVER, AS THE ERROR TYPE WAS NOT LOGGED, THE ROOT CAUSE FOR THE ISSUE CANNOT BE DETERMINED." }, { "mdr_text_key": "174316307", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AT ROUGHLY 10:12 AM, COMMUNICATION ERROR OCCURRED. ROBOT HAD BEEN IN AXIAL SLOW COOPERATIVE MODE, ON 'HIPPO HEAD' TRAJECTORY. SURGEON HAD MOVED TOWARDS TRAJECTORY, BUT COLLIDED WITH MAYFIELD. PATIENT WAS POSITIONED HEAD FACING TOWARDS LEFT, ALL TRAJECTORIES FACING UPWARD. MAYFIELD WAS POSITIONED WITH ATTACHMENT ANTERIOR TO PATIENT. COMPANY FIELD SERVICE ENGINEER (FSE) ATTEMPTED TO RESTART ROBOT THREE TIMES WITH FULL SHUTDOWN PROCEDURE. ON FOURTH ATTEMPT, SURGEON APPLIED SLIGHT FORCE TO MAYFIELD TO MOVE AWAY FROM POINT OF COLLISION. ROBOT WAS ABLE TO CONNECT. FSE EXPLAINED IMPORTANCE OF ACCURACY AND REGISTRATION VERIFICATION. SURGEON PROCEEDED WITH VERIFICATION OF ARM POSITION WITH INCISION PREVIOUSLY MADE ON TRAJECTORY. POST-OPERATIVE CT WAS UNAVAILABLE TO FSE, BUT SURGEON SENT EMAIL CONFIRMING CORRECT AND ACCURATE PLACEMENT ON CT FOLLOWING PROCEDURE. DELAY OF 30 MINUTES. SEEG PROCEDURE, ERROR OCCURRED ON 5TH OF 6 TRAJECTORIES." } ], "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": "" } ] }