{ "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": "3009185973-2019-00329", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20190925", "manufacturer_address_2": "", "pma_pmn_number": "K182417", "date_of_event": "20190827", "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": "20190925", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "911128", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190925", "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", "catalog_number": "N/A", "lot_number": "3.1.0.1276", "other_id_number": "", "device_availability": "Yes", "device_report_product_code": "HAW", "device_age_text": "", "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": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250805", "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": "20190925", "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": "20190925", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "9117751", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20190827", "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": "165546123", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT THE DEVICE CRASHED SYSTEMATICALLY WHEN STARTING THE VERIFICATION STEP. EVENT SUMMARY, DEVICE HISTORY RECORD REVIEW AND COMPLAINT HISTORY REVIEW DID NOT IDENTIFY CONTRIBUTING FACTORS. THE TECHNICAL INVESTIGATION CONFIRMED THAT DURING THIS SURGERY THE SOFTWARE CRASHED SYSTEMATICALLY WHEN A SCREENSHOT WAS TAKEN. THIS ISSUE WAS DUE TO THE PATIENT¿S NAME WHICH PROBABLY CONTAINED A SPECIAL CHARACTER (AS SS) NOT RECOGNIZED BY THE SOFTWARE. THIS ISSUE HAS BEEN RECORDED AS A NEW DESIGN DEFECT. (B)(4) NO CODE AVAILABLE' WAS SELECTED AS THE SURGERY WAS CONVERTED WHICH IS CONSIDERED TO BE A SERIOUS INJURY. UNIQUE IDENTIFIER (UDI) #: (B)(4)." }, { "mdr_text_key": "165546124", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE FIELD SERVICE ENGINEER SENT AN EMAIL ON 27-AUG-2019 WITH THE FOLLOWING INFORMATION: PLEASE RECORD A NEW COMPLAINT - ROBOT CRASHING AFTER REGISTRATION OF THE PATIENT WITH LASER REGISTRATION, WHEN ACCEPTING THE MERGE OF THE AUTOMATIC SCAN WITH THE 3D-MASH. SO BEFORE STARTING THE VERIFICATION. SURGEON TRIED THIS 2 TIMES WITH THE LASER. SAME ERROR OCCURRED WITH LANDMARK REGISTRATION WITH THE POINTER. ROBOT AGAIN CRASHED WHEN STARTING VERIFICATION STEP. ENDOSCOPY CASE CANCELLED. BIOPSY WHICH WAS PLANNED AFTER WITH THE ROBOT SWITCHED TO VARIOGUIDE. THE FIELD SERVICE ENGINEER SENT AN EMAIL ON 02-SEP-2019 WITH THE FOLLOWING INFORMATION: FOR FURTHER EXPLANATION: HE WAS THERE ON FRIDAY ((B)(6) 2019) AND COLLECTED THE LOG-FILES AND DID SOME TESTS. HE CHECKED, THAT THE ERROR OCCURRED ONLY ON THIS PATIENT FOLDER. THE MAINTENANCE PATIENT FOLDER IS WORKING PERFECTLY. HE ALSO REIMPORTED THE PATIENT FOLDER AGAIN FROM THE LAPTOP. THE ERROR WAS THE SAME. EVERYTIME, WHEN ENTERING VERIFICATION, THE SYSTEM CRASHED. THE WINDOWS ERROR MESSAGE WAS (B)(4) HAS STOPPED WORKING. THE (B)(4) LOGS SHOW AN UNKNOWN ERROR/EXCEPTION." } ], "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": "" } ] }