{ "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": "3009185973-2018-00339", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20181214", "manufacturer_address_2": "", "pma_pmn_number": "K172444", "date_of_event": "20181116", "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": [ "HEALTH PROFESSIONAL" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20181214", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1005690", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20181214", "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": "MI", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "01/17/2019", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250813", "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": "20181214", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Patient Involvement", "No Code Available", "No Patient Involvement", "No Code Available" ] } ], "distributor_city": "", "date_report": "20190215", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8163486", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20181116", "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": "312101697", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT THE SURGEON WAS UNABLE TO LOAD EXAMS ON THE ROBOT PC BUT WAS ABLE TO DO SO ON THE LAPTOP. A DHR REVIEW AND A COMPLAINT HISTORY REVIEW WERE PERFORMED AND DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. A FULL ANALYSIS OF DATA LOGS INDICATED THAT THE CAUSE OF THE ISSUE IS A USE ERROR. INDEED THE SURGEON DID NOT RESPECT THE ACQUISITION PROTOCOL RECOMMENDATIONS REGARDING THE NUMBER OF SLICES AND THEIR RESOLUTION. (B)(4)." }, { "mdr_text_key": "312101698", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "FIELD SERVICE ENGINEER ASSISTED DR. (B)(6) AT SPECTRUM HEALTH WITH AN ABLATION CASE ON 16/NOV/2018, USING ROBOT BR18075. THE START OF THE CASE WAS DELAYED BY AROUND 3 HOURS. FIELD SERVICE ENGINEER OBTAINED THE CD WITH CT AND MR DATA FOR THE CASE AROUND 7:30AM, THE PLAN WAS NOT CREATED YET AT THIS POINT. THE CST NOTED THE CT SCAN WAS OVER 400 SLICES, AND THE MR SCAN WAS OVER 300 SLICES. THE SURGEON WAS NOTIFIED THAT IMAGE SETS WITH OVER 255 SLICES MAY CAUSE AN ISSUE WITH UPLOADING. FIELD SERVICE ENGINEER CONFIRMED THE HOSPITAL HAD THE IMAGE PROTOCOL FOR ROSA CASES." }, { "mdr_text_key": "130313779", "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": "130313780", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "FIELD SERVICE ENGINEER ASSISTED DOCTOR (B)(6) AT SPECTRUM HEALTH WITH AN ABLATION CASE ON (B)(6) 2018, USING ROBOT (B)(4). THE START OF THE CASE WAS DELAYED BY AROUND 3 HOURS. FIELD SERVICE ENGINEER OBTAINED THE CD WITH CT AND MR DATA FOR THE CASE AROUND 7:30AM, THE PLAN WAS NOT CREATED YET AT THIS POINT. THE CST NOTED THE CT SCAN WAS OVER 400 SLICES, AND THE MR SCAN WAS OVER 300 SLICES. THE SURGEON WAS NOTIFIED THAT IMAGE SETS WITH OVER 255 SLICES MAY CAUSE AN ISSUE WITH UPLOADING. FIELD SERVICE ENGINEER CONFIRMED THE HOSPITAL HAD THE IMAGE PROTOCOL FOR (B)(6) CASES." } ], "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": "02/15/2019" } ] }