{ "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": "3009185973-2019-00173", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20190603", "manufacturer_address_2": "", "pma_pmn_number": "K172444", "date_of_event": "20190507", "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": "20190603", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "456801", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190603", "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": "ROSA BRAIN", "catalog_number": "N/A", "lot_number": "3.0.0.21", "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": [ "Failure to Calibrate", "Failure to Calibrate" ], "reporter_state_code": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/10/2019;07/31/2019", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250804", "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": "20190603", "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": "20190731", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8663074", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20190507", "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": "146810988", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "UDI# : (B)(4). THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION IS PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED." }, { "mdr_text_key": "146810989", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE ROBOT, (B)(4), WAS ROLLED OVER TO STANFORD FROM THE LUCILE PACKARD (STANFORD CHILDREN¿S) SIDE OF THE HOSPITAL. WHEN THE SURGEON WAS READY TO PERFORM REGISTRATION, THE FIELD SERVICE ENGINEERS SWITCHED TO THE REGISTRATION TAB AND BEGAN CALIBRATING THE FORCE SENSOR. THE FORCE SENSOR CALIBRATED CORRECTLY BY ITSELF, BUT WHEN THE POINTER (S18130) WAS ATTACHED, THE ROBOT PROVIDED THE MESSAGE OF A CALIBRATION ERROR. CALIBRATION WAS RETRIED MULTIPLE TIMES WITHOUT SUCCESS. THE FIELD SERVICE ENGINEERS ATTEMPTED TO CALIBRATE THE DISTANCE SENSOR (S18082) ON THE FORCE SENSOR, WHICH PROVIDED THE SAME CALIBRATION ERROR. RESTARTING THE ROBOT AND RELOADING THE POINTER CALIBRATION FILE DID NOT FIX THE ISSUE. THE FIELD SERVICE ENGINEERS THEN REMOVED AND RESEATED THE INTERFACE PLATE (MT- 02-249 S18182) ONTO THE FORCE SENSOR BLOCK. THIS FIXED THE PROBLEM AND THE SURGERY WAS ABLE TO CONTINUE. DELAY TO CASE ABOUT 1 HOUR, NO PATIENT IMPACT, PATIENT UNDER ANESTHESIA." }, { "mdr_text_key": "312103095", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT A CALIBRATION ERROR MESSAGE APPEARED WHILE THE POINTER PROBE WAS BEING CALIBRATED. DHR REVIEW AND REVIEW OF COMPLAINT HISTORY DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. ACCORDING TO TECHNICAL INVESTIGATION THE CALIBRATION OF POINTER AND DISTANCE SENSOR COULD NOT PASS DUE TO AN INCORRECT EMPTY CALIBRATION ON THE FORCE SENSOR. THE REINSTALLATION OF THE INTERFACE PLATE MADE THE TOOLS CALIBRATION PASS AGAIN. THEREFORE, IT IS PROBABLE THAT THE INTERFACE PLATE BECAME SLIGHTLY LOOSE WHEN THE ROBOT WAS TRANSPORTED BETWEEN TWO HOSPITALS." }, { "mdr_text_key": "312103096", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE ROBOT, BR18057, WAS ROLLED OVER TO STANFORD FROM THE LUCILE PACKARD (STANFORD CHILDREN¿S) SIDE OF THE HOSPITAL. WHEN THE SURGEON WAS READY TO PERFORM REGISTRATION, THE FIELD SERVICE ENGINEERS SWITCHED TO THE REGISTRATION TAB AND BEGAN CALIBRATING THE FORCE SENSOR. THE FORCE SENSOR CALIBRATED CORRECTLY BY ITSELF, BUT WHEN THE POINTER (S18130) WAS ATTACHED, THE ROBOT PROVIDED THE MESSAGE OF A CALIBRATION ERROR.CALIBRATION WAS RETRIED MULTIPLE TIMES WITHOUT SUCCESS. THE FIELD SERVICE ENGINEERS ATTEMPTED TO CALIBRATE THE DISTANCE SENSOR (S18082) ON THE FORCE SENSOR, WHICH PROVIDED THE SAME CALIBRATION ERROR. RESTARTING THE ROBOT AND RELOADING THE POINTER CALIBRATION FILE DID NOT FIX THE ISSUE. THE FIELD SERVICE ENGINEERS THEN REMOVED AND RESEATED THE INTERFACE PLATE (MT- 02-249 S18182) ONTO THE FORCE SENSOR BLOCK. THIS FIXED THE PROBLEM AND THE SURGERY WAS ABLE TO CONTINUE. DELAY TO CASE ABOUT 1 HOUR, NO PATIENT IMPACT, PATIENT UNDER ANESTHESIA." }, { "mdr_text_key": "312104581", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "WHILE REVIEWING COMPLAINT FOR CLOSURE, IT WAS NOTICED THAT THE UDI NUMBER THAT WAS PROVIDED IN THE MEDWATCH 3009185973-2019-00173 WAS INCORRECT. THEREFORE, A NEW MEDWATCH IS SENT TO PROVIDE THE CORRECT UDI NUMBER.(B)(4)." }, { "mdr_text_key": "312104582", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE ROBOT, BR18057, WAS ROLLED OVER TO STANFORD FROM THE LUCILE PACKARD (STANFORD CHILDREN¿S) SIDE OF THE HOSPITAL. WHEN THE SURGEON WAS READY TO PERFORM REGISTRATION, THE FIELD SERVICE ENGINEERS SWITCHED TO THE REGISTRATION TAB AND BEGAN CALIBRATING THE FORCE SENSOR. THE FORCE SENSOR CALIBRATED CORRECTLY BY ITSELF, BUT WHEN THE POINTER (S18130) WAS ATTACHED, THE ROBOT PROVIDED THE MESSAGE OF A CALIBRATION ERROR. CALIBRATION WAS RETRIED MULTIPLE TIMES WITHOUT SUCCESS. THE FIELD SERVICE ENGINEERS ATTEMPTED TO CALIBRATE THE DISTANCE SENSOR (S18082) ON THE FORCE SENSOR, WHICH PROVIDED THE SAME CALIBRATION ERROR. RESTARTING THE ROBOT AND RELOADING THE POINTER CALIBRATION FILE DID NOT FIX THE ISSUE. THE FIELD SERVICE ENGINEERS THEN REMOVED AND RESEATED THE INTERFACE PLATE (MT- 02-249 S18182) ONTO THE FORCE SENSOR BLOCK. THIS FIXED THE PROBLEM AND THE SURGERY WAS ABLE TO CONTINUE. DELAY TO CASE ABOUT 1 HOUR, NO PATIENT IMPACT, PATIENT UNDER ANESTHESIA." } ], "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": "06/13/2019;07/31/2019" } ] }