{ "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": "3009185973-2019-00263", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20190805", "manufacturer_address_2": "", "pma_pmn_number": "K101791", "date_of_event": "20190718", "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": "652903", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190805", "brand_name": "ROSA SURGICAL DEVICE", "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 2.5", "catalog_number": "ROSA", "lot_number": "2.5.8.4", "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": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "10/28/2019", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250804", "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": "20191030", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8859285", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20190718", "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": "312105769", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT A COMMUNICATION ERROR OCCURRED DURING A SURGERY AND PATIENT FOLDER WAS NOT ABLE TO BE LOADED WHICH LED TO REVERT TO TRADITIONAL SURGERY. DHR REVIEW AND REVIEW OF COMPLAINT HISTORY DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. ACCORDING TO TECHNICAL INVESTIGATION, A COMMUNICATION ERROR OCCURRED DUE TO A TIMEOUT SUPERIOR TO 10 SECONDS DETECTED IN THE COOPERATIVE MODE THREAD. THE CONTROLLER STOPPED THE COMMUNICATION CHANNEL RELATED TO THE BRAKES. THE CAUSE FOR THE TIMEOUT IS UNKNOWN BUT THE DEVICE BEHAVED AS EXPECTED. AFTER THE REBOOT, THE PATIENT FOLDER COULD NO MORE BE LOADED DUE TO A KNOWN ANOMALY." }, { "mdr_text_key": "312105770", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE SURGEON INFORMED THE FIELD SERVICE ENGINEER BY PHONE, THAT HE HAD SOME ISSUES DURING THE ENDOSCOPY CASE. HE DID THE REGISTRATION AND WANTED TO SENT ROSA ON TRAJECTORY. THE TRAJECTORY WAS NOT REACHABLE FOR THE ROBOT. THE SURGEON SWITCHED TO POSITION FOR NAVIGATION. HE THEN PUSHED THE ARM DOWN ALONG TRAJECTORY AND HAD A COMMUNICATION ERROR OCCURRED. AFTER RESTARTING THE SYSTEM, THE PATIENT FOLDER WAS NOT READ/LOADABLE ANY MORE. THE SURGEON DID NOT WANT TO REREGISTER THE PATIENT AND DECIDED TO DO THE SURGERY WITHOUT THE ROBOT." }, { "mdr_text_key": "153215689", "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": "153215690", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE SURGEON INFORMED THE FIELD SERVICE ENGINEER BY PHONE, THAT HE HAD SOME ISSUES DURING THE ENDOSCOPY CASE. HE DID THE REGISTRATION AND WANTED TO SENT ROSA ON TRAJECTORY. THE TRAJECTORY WAS NOT REACHABLE FOR THE ROBOT. THE SURGEON SWITCHED TO POSITION FOR NAVIGATION. HE THEN PUSHED THE ARM DOWN ALONG TRAJECTORY AND HAD A COMMUNICATION ERROR OCCURED. AFTER RESTARTING THE SYSTEM, THE PATIENT FOLDER WAS NOT READ/LOADABLE ANY MORE. THE SURGEON DID NOT WANT TO REREGISTER THE PATIENT AND DECIDED TO DO THE SURGERY WITHOUT THE ROBOT." } ], "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": "10/30/2019" } ] }