{ "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": "3009185973-2019-00370", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20191024", "manufacturer_address_2": "", "pma_pmn_number": "K172444", "date_of_event": "20190926", "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": "20191024", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1026428", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20191024", "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 3.0", "catalog_number": "ROSA BRAIN", "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": [ "Unintended Collision", "Unintended Collision" ], "reporter_state_code": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "12/31/2019;04/10/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250731", "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": "20191024", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Information", "No Information" ] } ], "distributor_city": "", "date_report": "20200414", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "9231431", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20190926", "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": "316212428", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "NUMBER OF THE INITIAL MEDWATCH SENT BY THE CUSTOMER FACILITY IS (B)(4)." }, { "mdr_text_key": "316212429", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "AS THE VERIFICATION STAGE WAS OVER, THE FIELD SERVICE ENGINEER COMMUNICATED CLEARING THE ARM ON 'FREE AND FAST'. THE ARM WASN'T CLEARED ALL THE DUE TO THE RESIDENT WANTING TO CHECK ANOTHER POINT NEAR THE TEMPLE, THAT IN TURN RESULTED IN A COLLISION AS THE ARM WASN'T CLEARED. THE ROSA DETECTED A COLLISION AND SHUT DOWN, THE FIELD SERVICE ENGINEER ENGAGED THE EMERGENCY BUTTON AND A MANUAL CLEARING OF THE POINTER PROBE WAS DONE." }, { "mdr_text_key": "317767630", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "AS THE VERIFICATION STAGE WAS OVER, THE FIELD SERVICE ENGINEER COMMUNICATED CLEARING THE ARM ON FREE AND FAST. THE ARM WASN'T CLEARED ALL THE DUE TO THE RESIDENT WANTING TO CHECK ANOTHER POINT NEAR THE TEMPLE, THAT IN TURN RESULTED IN A COLLISION AS THE ARM WASN'T CLEARED. THE ROSA DETECTED A COLLISION AND SHUT DOWN, THE FIELD SERVICE ENGINEER ENGAGED THE EMERGENCY BUTTON AND A MANUAL CLEARING OF THE POINTER PROBE WAS DONE." }, { "mdr_text_key": "317767631", "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 A COMMUNICATION ERROR AND A ROBOT SHUTDOWN OCCURRED DUE TO A COLLISION. THE USER DID NOT CLEAR THE ARM BEFORE TO LAUNCH THE AUTOMATIC MOVE OF THE CLEARANCE PROCEDURE.MOREOVER, THE COLLISION SHOULD HAVE BEEN AVOIDED BY RELEASING THE VIGILANCE DEVICE REGARDING THE IFU RECOMMENDATION. THE COLLISION IS DUE TO A USER ERROR AND THE DEVICE BEHAVED AS EXPECTED." }, { "mdr_text_key": "173185541", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "UDI: (B)(4). (B)(4) WAS CHOSEN BECAUSE THE EVENT CONTRIBUTED TO A SERIOUS INJURY OF THE PATIENT AS THERE WAS SOFT TISSUE DAMAGE AND THE DELAY EXCEEDED THE 30 MINUTES IN ORDER TO SUTURE THE COLLISION WOUNDS. 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": "173185542", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS THE VERIFICATION STAGE WAS OVER, THE FIELD SERVICE ENGINEER COMMUNICATED CLEARING THE ARM ON 'FREE AND FAST'. THE ARM WASN'T CLEARED ALL THE DUE TO THE RESIDENT WANTING TO CHECK ANOTHER POINT NEAR THE TEMPLE, THAT IN TURN RESULTED IN A COLLISION AS THE ARM WASN'T CLEARED. THE ROSA DETECTED A COLLISION AND SHUT DOWN, THE FIELD SERVICE ENGINEER ENGAGED THE EMERGENCY BUTTON AND A MANUAL CLEARING OF THE POINTER PROBE WAS DONE." } ], "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": "01/30/2020;04/14/2020" } ] }