{ "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": "3009185973-2019-00222", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20190626", "manufacturer_address_2": "", "pma_pmn_number": "K172444", "date_of_event": "20190529", "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": "US", "manufacturer_contact_area_code": "", "date_added": "20190626", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "529305", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190626", "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": "HEALTH PROFESSIONAL", "model_number": "VIGILANCE DEVICE PEDAL", "catalog_number": "ROSAP00535", "lot_number": "1330859", "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": [ "Defective Component", "Defective Component" ], "reporter_state_code": "TN", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "03/18/2020", "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": "20190626", "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": "20200323", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8734995", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20190529", "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": "317077671", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE PROCEDURE WAS A SHUNT CASE AND ONE TRAJECTORY. SURGEON AND FIELD SERVICE ENGINEER WERE JUST MAKING SURE THAT THE FOOT PEDAL WOULD WORK, SINCE THIS HAS BEEN A REOCCURRING ISSUE, SO THE PATIENT HADN'T YET BEEN PINNED OR ATTACHED TO THE ROBOT. THE SURGEON PLANNED ON DOING CONTACTLESS REGISTRATION SO HE SELECTED THAT OPTION. THE \"BOOM, CLICK\" SOUND OF THE ROBOT CONNECTING TO THE CONTROLLER WAS HEARD. SURGEON AND FIELD SERVICE ENGINEER WERE THEN GIVEN THE PROMPT ON THE SCREEN TO STEP ON THE FOOT PEDAL SO THE ARM WOULD GO TO THE HOME POSITION. WHEN THE SURGEON STEPPED ON THE FOOT PEDAL/VIGILANCE DEVICE THE PROMPT CAME UP THAT HE HAD TAKEN OUR FOOT OFF THE PEDAL (NOT TRUE) AND THEN HE CYCLED THROUGH THE STEPS TO TRY TO MOVE THE ARM. SURGEON AND FIELD SERVICE ENGINEER COULDN'T RESOLVE THIS ISSUE. SO THEY RESTARTED THE ROBOT. THEY REPEATED THESE EXACT STEPS, PLUS ADDITIONALLY UNPLUGGING/REPLUGGING THE VIGILANCE DEVICE INTO THE ROBOT 4 TIMES. NONE OF THE ATTEMPTS WORKED. SURGEON AND FIELD SERVICE ENGINEER CAME TO THE COLLECTIVE DECISION TO NOT TRY AGAIN AND PROCEED TO THE CASE WITHOUT USING ROSA (POSSIBLE IN THIS SITUATION). THERE WAS NO MEDICAL INTERVENTION AND THERE WAS NO DELAY TO THE START OF THE PROCEDURE." }, { "mdr_text_key": "317077672", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A SURGERY, WHEN THE VIGILANCE DEVICE WAS PRESSED, THE SOFTWARE GAVE A MESSAGE ASKING TO PRESS THE VIGILANCE DEVICE SEVERAL TIMES. SURGERY WAS THEN CONVERTED TO TRADITIONAL SURGERY. DHR REVIEW DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. REVIEW OF COMPLAINT HISTORY SHOWED THAT TWO SIMILAR COMPLAINTS WERE RECEIVED WITH THE SAME ROOT CAUSE. ACCORDING TO TECHNICAL INVESTIGATION THE ISSUE WAS CAUSED BY A FAULTY WIRING OF THE CONNECTOR OF THE VIGILANCE DEVICE. THIS CONNECTOR WAS REPLACED. CORRECTED DATA: B4: DATE OF THIS REPORT. G4: DATE RECEIVED BY MANUFACTURER. H2: IF FOLLOW-UP, WHAT TYPE. H3: DEVICE EVALUATED BY MANUFACTURER. H6: EVENT PROBLEM AND EVALUATION CODES." }, { "mdr_text_key": "149209144", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSES. ONCE THE EVALUATION IS PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED." }, { "mdr_text_key": "149209145", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE PROCEDURE WAS A SHUNT CASE AND ONE TRAJECTORY. SURGEON AND FIELD SERVICE ENGINEER WERE JUST MAKING SURE THAT THE FOOT PEDAL WOULD WORK, SINCE THIS HAS BEEN A REOCCURRING ISSUE, SO THE PATIENT HADN'T YET BEEN PINNED OR ATTACHED TO THE ROBOT. THE SURGEON PLANNED ON DOING CONTACTLESS REGISTRATION SO HE SELECTED THAT OPTION. THE \"BOOM, CLICK\" SOUND OF THE ROBOT CONNECTING TO THE CONTROLLER WAS HEARD. SURGEON AND FIELD SERVICE ENGINEER WERE THEN GIVEN THE PROMPT ON THE SCREEN TO STEP ON THE FOOT PEDAL SO THE ARM WOULD GO TO THE HOME POSITION. WHEN THE SURGEON STEPPED ON THE FOOT PEDAL/VIGILANCE DEVICE THE PROMPT CAME UP THAT HE HAD TAKEN OUR FOOT OFF THE PEDAL (NOT TRUE) AND THEN HE CYCLED THROUGH THE STEPS TO TRY TO MOVE THE ARM. SURGEON AND FIELD SERVICE ENGINEER COULDN'T RESOLVE THIS ISSUE. SO THEY RESTARTED THE ROBOT. THEY REPEATED THESE EXACT STEPS, PLUS ADDITIONALLY UNPLUGGING/REPLUGGING THE VIGILANCE DEVICE INTO THE ROBOT 4 TIMES. NONE OF THE ATTEMPTS WORKED. SURGEON AND FIELD SERVICE ENGINEER CAME TO THE COLLECTIVE DECISION TO NOT TRY AGAIN AND PROCEED TO THE CASE WITHOUT USING ROSA (POSSIBLE IN THIS SITUATION). THERE WAS NO MEDICAL INTERVENTION AND THERE WAS NO DELAY TO THE START OF THE PROCEDURE." } ], "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": "03/23/2020" } ] }