{ "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": "3009185973-2019-00142", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20190411", "manufacturer_address_2": "", "pma_pmn_number": "K151359", "date_of_event": "20190319", "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": "AS", "manufacturer_contact_area_code": "", "date_added": "20190411", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "297475", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190411", "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": "OPTICAL DISTANCE SENSOR", "catalog_number": "N/A", "lot_number": "N/A", "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": [ "Mechanical Jam", "Mechanical Jam" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/18/2019", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250730", "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": "20190411", "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": "20190715", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8502901", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20190319", "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": "312103295", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT THE OPTICAL DISTANCE SENSOR CABLE BECAME PINCHED IN THE ROBOT ARM JOINT DURING THE REGISTRATION. AFTER IT WAS RELEASED, THE DEVICE WAS RESTARTED BUT THE SYSTEM ASKED TO CONFIRM CALIBRATION OF DISTANCE SENSOR LASER TOOL REPEATEDLY. EVENT SUMMARY, DEVICE HISTORY RECORD REVIEW AND COMPLAINT HISTORY REVIEW DID NOT IDENTIFY CONTRIBUTING FACTORS. THE INVESTIGATION FOUND FOUR DIFFERENT EVENTS: - A FIRST COMMUNICATION ERROR DUE TO THE PINCHED CABLE. THE ROBOT WORKED AS EXPECTED, THIS ISSUE CAN BE CONSIDERED AS A USE ERROR. - A CONNECTION FAILURE, NOT REPORTED, DUE TO THE A KNOWN DESIGN DEFECT. - SEVERAL CALIBRATION ISSUES DUE TO THE FACT THE THE TOOL WAS MOUNTED ON DURING THE EMPTY CALIBRATION STEP, THIS ISSUE CAN BE CONSIDERED AS A MISUSE. - A DEVICE SHUTDOWN DURING GUIDANCE, NOT REPORTED, EITHER DUE TO A CRASH OF THE SOFTWARE OR OF THE OPERATING SYSTEM. NOT ENOUGH ELEMENTS ARE PROVIDED TO DETERMINE WHICH IS THE ROOT CAUSE." }, { "mdr_text_key": "312103296", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT THE DISTANCE SENSOR CABLE BECAME PINCHED IN THE FINAL ROBOT ARM JOINT DURING THE REGISTRATION. THE SYSTEM FROZE AND IT WAS NOT POSSIBLE TO RESTART OR SEND THE ROBOT ARM TO THE HOME POSITION. THE FIELD SERVICE ENGINEER EXITED THE CASE APPLICATION AND ENTERED THE MAINTENANCE MODE TO LOAD THE KINEVERIF PROGRAM, AFTER WHICH HE WAS ABLE TO DRIVE THE ROBOT TO THE HOME POSITION AND TO RELEASE THE CABLE. IT WAS THE HARD CASE PART OF THE CABLE THAT BECAME TRAPPED. THERE WERE SOME PRESSURE MARKS VISIBLE ON THE INSULATION, BUT NO SIGNS OF DAMAGE TO THE ACTUAL CABLE. THE DEVICE WAS RESTARTED BUT THE SYSTEM WOULDN¿T PROGRESS PAST ASKING TO CONFIRM CALIBRATION OF DISTANCE SENSOR LASER TOOL. AFTER MULTIPLE ATTEMPTS THE DEVICE WAS TURNED OFF ENTIRELY AND REBOOTED. AFTER THIS THE DEVICE WORKED AS INTENDED." }, { "mdr_text_key": "141563636", "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": "141563637", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT THE DISTANCE SENSOR CABLE BECAME PINCHED IN THE FINAL ROBOT ARM JOINT DURING THE REGISTRATION. THE SYSTEM FROZE AND IT WAS NOT POSSIBLE TO RESTART OR SEND THE ROBOT ARM TO THE HOME POSITION. THE FIELD SERVICE ENGINEER EXITED THE CASE APPLICATION AND ENTERED THE MAINTENANCE MODE TO LOAD THE KINEVERIF PROGRAM, AFTER WHICH HE WAS ABLE TO DRIVE THE ROBOT TO THE HOME POSITION AND TO RELEASE THE CABLE. IT WAS THE HARD CASE PART OF THE CABLE THAT BECAME TRAPPED. THERE WERE SOME PRESSURE MARKS VISIBLE ON THE INSULATION, BUT NO SIGNS OF DAMAGE TO THE ACTUAL CABLE. THE DEVICE WAS RESTARTED BUT THE SYSTEM WOULDN¿T PROGRESS PAST ASKING TO CONFIRM CALIBRATION OF DISTANCE SENSOR LASER TOOL. AFTER MULTIPLE ATTEMPTS THE DEVICE WAS TURNED OFF ENTIRELY AND REBOOTED. AFTER THIS THE DEVICE WORKED AS INTENDED." } ], "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": "07/15/2019" } ] }