{ "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": "3009185973-2020-00171", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200723", "manufacturer_address_2": "", "pma_pmn_number": "K182417", "date_of_event": "20200714", "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": "20200723", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "776900", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200723", "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": "ROSAS00203", "lot_number": "3.1.1.1295", "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": [ "Noise, Audible", "Application Program Freezes or Fails to Launch", "Noise, Audible", "Application Program Freezes or Fails to Launch" ], "reporter_state_code": "PA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "12/10/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250806", "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": "20200723", "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": "20201215", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10312575", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20200714", "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": "200038783", "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": "200038784", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON THE MORNING OF (B)(6) 2020, THE SURGEON WAS USING ROSA TO IMPLANT A RNS DEVICE. DURING THE FIRST ATTEMPT OF REGISTRATION THE ROBOT HAD A 'UNRECOVERABLE ERROR' AND SHUTDOWN. THIS WAS AFTER THE INITIAL REGISTRATION POINTS WERE PLACED AND TWO OF THE POINTS HAD BEEN ADJUSTED FOR ACCURACY. THE ARM MOVED TO THE INTERMEDIATE POSITION AND THEN WAS ABOUT TO START THE AUTOMATIC SCAN OF THE PATIENT'S FOREHEAD WHEN IT SHUTDOWN. THE ROBOT WAS REBOOTED AND THE REGISTRATION PROCESS WAS STARTED AGAIN. DURING THE MATCHING OF THE INITIAL REGISTRATION POINTS, THE ROBOTIC ARM BEGAN TO MAKE A GRINDING NOISE AT THE 2ND JOINT FROM THE BASE. THIS SOUND WAS NOT A HUMMING NOISE, BUT A MECHANICAL GRINDING NOISE. THE ARM WAS IN POSITION TO COLLECT THE DATA POINT FROM THE LEFT LATERAL CANTHUS AND THE ARM WAS NOT BEING MOVED WITH EXCESSIVE FORCE. THE MOVEMENT OF THE ARM COULD BE DESCRIBED AS NORMAL. THE SURGEON NOTICED THE SOUND/FEEDBACK FROM THE ARM AND ALERTED THE COMPANY FIELD SERVICE ENGINEER. ROUGHLY, 5 SECONDS PASSED AND THE ROBOT HAD THE SAME ERROR IT HAD BEFORE. RESTARTED THE ROBOT AND TRIED TO CONNECT TO THE CONTROLLER AND CONTINUE WITH THE SURGERY, BUT THE ROBOT WOULD NOT CONNECT. THE USE OF ROSA FOR THE PROCEDURE WAS ABORTED, BUT THE SURGERY CONTINUED. AFTER ROSA WAS REMOVED FROM THE ROOM, THERE WERE MULTIPLE ATTEMPTS AT CONNECTING TO THE CONTROLLER WITHOUT ANY SUCCESS. THE ARM WAS ALSO MANUALLY RELEASED BUT THAT DID NOT SOLVE THE ISSUE. THE DELAY IN THE OR WAS APPROXIMATELY 30MINUTES. THERE WAS NO PATIENT INVOLVEMENT." }, { "mdr_text_key": "321740841", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A FULL ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED. THIS ANALYSIS CONCLUDED THAT THE FIRST FAILURE TO CONNECT TO THE ARM WAS DUE TO AN INCOMPLETE INITIALIZATION OF THE STARC ELECTRONIC BOARD. IT WAS SOLVED BY SHUTTING DOWN AND RESTARTING THE DEVICE. THE FOLLOWING FAILURES TO CONNECT TO THE ARM WERE DUE TO A KNOWN SOFTWARE ANOMALY." }, { "mdr_text_key": "321740842", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ON THE MORNING OF (B)(6) 2020, THE SURGEON WAS USING ROSA TO IMPLANT A RNS DEVICE. DURING THE FIRST ATTEMPT OF REGISTRATION THE ROBOT HAD A 'UNRECOVERABLE ERROR' AND SHUTDOWN. THIS WAS AFTER THE INITIAL REGISTRATION POINTS WERE PLACED AND TWO OF THE POINTS HAD BEEN ADJUSTED FOR ACCURACY. THE ARM MOVED TO THE INTERMEDIATE POSITION AND THEN WAS ABOUT TO START THE AUTOMATIC SCAN OF THE PATIENT'S FOREHEAD WHEN IT SHUTDOWN. THE ROBOT WAS REBOOTED AND THE REGISTRATION PROCESS WAS STARTED AGAIN. DURING THE MATCHING OF THE INITIAL REGISTRATION POINTS, THE ROBOTIC ARM BEGAN TO MAKE A GRINDING NOISE AT THE 2ND JOINT FROM THE BASE. THIS SOUND WAS NOT A HUMMING NOISE, BUT A MECHANICAL GRINDING NOISE. THE ARM WAS IN POSITION TO COLLECT THE DATA POINT FROM THE LEFT LATERAL CANTHUS AND THE ARM WAS NOT BEING MOVED WITH EXCESSIVE FORCE. THE MOVEMENT OF THE ARM COULD BE DESCRIBED AS NORMAL. THE SURGEON NOTICED THE SOUND/FEEDBACK FROM THE ARM AND ALERTED THE COMPANY FIELD SERVICE ENGINEER. ROUGHLY, 5 SECONDS PASSED AND THE ROBOT HAD THE SAME ERROR IT HAD BEFORE. RESTARTED THE ROBOT AND TRIED TO CONNECT TO THE CONTROLLER AND CONTINUE WITH THE SURGERY, BUT THE ROBOT WOULD NOT CONNECT. THE USE OF ROSA FOR THE PROCEDURE WAS ABORTED, BUT THE SURGERY CONTINUED. AFTER ROSA WAS REMOVED FROM THE ROOM, THERE WERE MULTIPLE ATTEMPTS AT CONNECTING TO THE CONTROLLER WITHOUT ANY SUCCESS. THE ARM WAS ALSO MANUALLY RELEASED BUT THAT DID NOT SOLVE THE ISSUE. THE DELAY IN THE OR WAS APPROXIMATELY 30 MINUTES. THERE WAS NO PATIENT INVOLVEMENT." } ], "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": "12/15/2020" } ] }