{ "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": "3009185973-2019-00049", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20190219", "manufacturer_address_2": "", "pma_pmn_number": "K172444", "date_of_event": "20190122", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20190219", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "144771", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190219", "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": "0", "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": "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": [ "Mechanical Problem", "Mechanical Problem" ], "reporter_state_code": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/28/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250811", "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": "20190219", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Code Available", "No Code Available" ] } ], "distributor_city": "", "date_report": "20200831", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8349896", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20190122", "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": "136479973", "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. (B)(4)." }, { "mdr_text_key": "136479974", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AT THE BEGINNING OF A SURGERY IT WAS NOTICED THAT THE CONNECTOR BETWEEN THE FORCE SENSOR AND THE ROBOT ARM WAS DAMAGED, THUS PREVENTING THE CONNECTION TO THE DEVICE. IT WAS NOT POSSIBLE TO REPAIR, THEREFORE THE SURGERY ASSISTED WITH ROSA WAS ABORTED, AND THE SURGERY WAS CONVERTED TO TRADITIONAL SURGERY." }, { "mdr_text_key": "319859905", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT THE CONNECTION BETWEEN THE ROBOT ARM AND THE FORCE SENSOR (S/N (B)(6)) WAS DISCONNECTED. THE CONNECTOR AND PINS WERE DAMAGED AND BENT. IT WAS CONFIRMED THAT THE FORCE SENSOR WILL NOT BE RETURNED TO THE MANUFACTURING SITE FOR INVESTIGATION. A VISUAL INSPECTION OF THE FORCE SENSOR WAS PERFORMED BASED ON THE PICTURES OF THE PRODUCT TAKEN ON THE EVENT DATE. THOSE PICTURES SHOW THAT SOME PINS ARE SLIGHTLY BENT AND THAT THE CONNECTOR IS DAMAGED. THEREFORE THE REPORTED EVENT IS CONFIRMED. HOWEVER BASED ON THE AVAILABLE ELEMENTS IT IS NOT POSSIBLE TO CONFIRM THE ROOT CAUSE FOR THE OBSERVED DAMAGE. THERE WAS NO DAMAGE NOTED TO THE FORCE SENSOR DURING THE PREVENTIVE MAINTENANCE THAT TOOK PLACE TWO WEEKS PRIOR TO THE DISCOVERY OF THE DAMAGE. THE MOST PROBABLE CAUSE IS ASSUMED TO BE AN UNINTENDED DEVICE MISUSE OR USE ERROR THAT LIKELY CAUSED AS A FORCE SENSOR CABLE ENTRAPMENT AND/OR A SHOCK ON ITS CONNECTOR. THE DAMAGED FORCE SENSOR WAS TEMPORARILY REPLACED ON (B)(6) 2019 WITH THE ONE FROM A DIFFERENT DEVICE, AND THE APPLICATIVE TESTS PERFORMED FOLLOWING THIS REPLACEMENT WERE PASS. A NEW FORCE SENSOR WAS INSTALLED ON (B)(6) 2019, AND THE APPLICATIVE AND ACCURACY TESTS PERFORMED FOLLOWING THIS REPLACEMENT WERE PASS." }, { "mdr_text_key": "319859906", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "AT THE BEGINNING OF A SURGERY IT WAS NOTICED THAT THE CONNECTOR BETWEEN THE FORCE SENSOR AND THE ROBOT ARM WAS DAMAGED, THUS PREVENTING THE CONNECTION TO THE DEVICE. IT WAS NOT POSSIBLE TO REPAIR, THEREFORE THE SURGERY ASSISTED WITH ROSA WAS ABORTED, AND THE SURGERY WAS CONVERTED TO TRADITIONAL SURGERY." } ], "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": "08/31/2020" } ] }