{ "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": "3009185973-2019-00273", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20190805", "manufacturer_address_2": "", "pma_pmn_number": "K182417", "date_of_event": "20190708", "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": "GM", "manufacturer_contact_area_code": "", "date_added": "20190805", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "654278", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190805", "brand_name": "ROSA ONE", "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 ONE 3.1", "catalog_number": "ROSA ONE", "lot_number": "3.1.0.1276", "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": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/07/2019", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250727", "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": "20190805", "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": "20190905", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8859350", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20190708", "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": "312108094", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT A COLLISION OCCURRED AND THEN THE ROBOT ARM WAS BLOCKED. A DHR REVIEW AND A COMPLAINT HISTORY REVIEW WERE PERFORMED AND DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. ANALYSIS OF DATA LOGS DETERMINED THAT THE COLLISION WAS DUE TO A USE ERROR. THEN IT DETERMINED THAT THE ROBOT ARM GET LOCKED DUE TO IT'S POSITION WHEN THE COLLISION OCCURRED. THIS IS A NORMAL BEHAVIOR OF THE DEVICE. ANALYSIS OF AVAILABLE DATA DID NOT REVEAL ANY DEVICE FAILURE. THE DEVICE OPERATED AS SPECIFIED.(B)(6)." }, { "mdr_text_key": "312108095", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE SURGEON CALLED HE FIELD SERVICE ENGINEER (FSE) TO ASK FOR A SOLUTION, HOW HE CAN GET THE ROBOT TO MOVE AGAIN, AFTER THE ROBOT HIT THE SUSTAINING ARM THE ROBOT SHOWED AN UNRECOVERABLE ERROR. THE ERROR APPEARED DIRECTLY AFTER RECONNECTING TO THE ROBOT, EVEN AFTER A COMPLETE COLD START (HARDWARE SWITCH OFF, WAITING UNTIL THE LIGHT ON THE RESET BUTTON IS OFF). FINALLY THE SURGEON REMOVED THE PATIENT, REMOVED THESUSTAINING ARM BY PULLING IT OUT, LEAVING A BIG SCRATCH ON THE SUSTAINING ARM. LIKE THIS THE REGISTRATION HAD TO BE DONE AGAIN. THE FSE ASSUMES A DELAY OF MORE THAN 30 MINUTES INCLUDING REGISTRATION." }, { "mdr_text_key": "153219920", "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": "153219921", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE SURGEON CALLED HE FIELD SERVICE ENGINEER (FSE) TO ASK FOR A SOLUTION, HOW HE CAN GET THE ROBOT TO MOVE AGAIN, AFTER THE ROBOT HIT THE SUSTAINING ARM THE ROBOT SHOWED AN UNRECOVERABLE ERROR. THE ERROR APPEARED DIRECTLY AFTER RECONNECTING TO THE ROBOT, EVEN AFTER A COMPLETE COLD START (HARDWARE SWITCH OFF, WAITING UNTIL THE LIGHT ON THE RESET BUTTON IS OFF). FINALLY THE SURGEON REMOVED THE PATIENT, REMOVED THE SUSTAINING ARM BY PULLING IT OUT, LEAVING A BIG SCRATCH ON THE SUSTAINING ARM. LIKE THIS THE REGISTRATION HAD TO BE DONE AGAIN. THE FSE ASSUMES A DELAY OF MORE THAN 30 MINUTES INCLUDING 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": "09/05/2019" } ] }