{ "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": "*", "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": "3009185973-2018-00178", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20180614", "manufacturer_address_2": "", "pma_pmn_number": "PK101791", "date_of_event": "20180613", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "HEALTH 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": "CA", "manufacturer_contact_area_code": "", "date_added": "20180614", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "446270", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20180614", "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 2.5.8", "catalog_number": "N/A", "lot_number": "2.5.8.4", "other_id_number": "N/A", "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", "Defective Component", "Computer Software Problem", "Defective Component" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/23/2018", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250801", "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": "20180614", "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": "20180907", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "7600300", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20180613", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Repair" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "111001040", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION WILL BE PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED." }, { "mdr_text_key": "111001041", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE SURGEON CALLED THE FIELD SERVICE ENGINEER ON (B)(6) 2018 DURING AN SEEG SURGERY. THE SURGEON REPORTED THAT TWO COMMUNICATION FAILURES OCCURRED DURING THE SURGERY. THE FIELD SERVICE ENGINEER WHO WAS NOT ON SITE RECEIVED THE CALL AND BEGAN TROUBLESHOOTING. THE ROBOT WAS UNPLUGGED AND MOVED TO A DIFFERENT OUTLET AND REBOOTED. THE ISSUE APPEARED TO RESOLVE AND THE ROBOT WAS ABLE TO BEGIN REGISTRATION. TROUBLESHOOTING TOOK APPROXIMATELY 20 MINUTES ON THE PHONE. THE DELAY TOTALED TO BE 115 MINUTES." }, { "mdr_text_key": "310460158", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE ANALYSIS OF SOFTWARE LOG FILES CONCLUDED THAT TWO COMMUNICATIONS ERROR WERE DETECTED. THE FIRST ONE OCCURRED DURING THE CALIBRATION OF THE DISTANCE SENSOR AND THE SECOND AFTER STARTING THE ROBOT ARM. BOTH WERE DUE TO A POWER MODULE OVERCURRENT ERROR DETECTED IN THE CONTROLLER WHICH LED TO THE ROBOT SHUTDOWN. FROM THIS ANALYSIS, IT WAS IDENTIFIED THAT THE ISSUE MAY HAVE BEEN DUE TO A DEFICIENT MOTOR CABLE OR SIMILAR COMPONENT. AN INTERVENTION OF THE SUPPLIER OF THE ROBOT ARM (MITSUBISHI) TOOK PLACE ON (B)(6) 2018. ACCORDING TO THE SUPPLIER TECHNICIANS, THERE WERE TWO MALFUNCTIONING PCB (PRINTED CIRCUIT BOARD) WHICH WERE CAUSING REPEATED COMMUNICATION FAILURES. A PREVENTIVE MAINTENANCE WAS PERFORMED ON (B)(6) 2018 AND INDICATED THAT THE ROBOT IS IN CONFORMANCE. CORRECTED DATA: DATE OF THIS REPORT. DEVICE CODE. DATE RECEIVED BY MANUFACTURER. IF FOLLOW-UP, WHAT TYPE. DEVICE EVALUATED BY MANUFACTURER. EVALUATION CODE. REMEDIAL ACTION." } ], "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": "09/07/2018" } ] }