{ "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": "3009185973-2019-00006", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20190115", "manufacturer_address_2": "", "pma_pmn_number": "K172444", "date_of_event": "20181218", "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": "20190115", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "40697", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190115", "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 3.0", "catalog_number": "ROSA BRAIN", "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": [ "Computer Software Problem", "Failure to Calibrate", "Computer Software Problem", "Failure to Calibrate" ], "reporter_state_code": "TX", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "09/09/2019", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250727", "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": "20190115", "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": "20190924", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8247158", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20181218", "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": "312111375", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE SURGEON WAS AT THE REGISTRATION (MARKERS) PHASE OF HIS SECOND SURGERY OF THE DAY AND WAS EXPERIENCING DIFFICULTY MOVING THE ROBOTIC ARM IN COOPERATIVE MODE. HE CLAIMED THAT DURING HIS FIRST SURGERY THIS DAY THE ROBOTIC ARM WAS VERY HARD TO MOVE AND DID NOT MOVE THE WAY HE INTENDED WHEN USING COOPERATIVE MODE. HE MENTIONED THAT AT ONE POINT THE ROBOT ARM MOVED WHEN HE STEPPED ON THE PEDAL AND WAS NOT TOUCHING IT. WHILE ON THE PHONE, HE CLAIMED THAT THE ARM WAS NOT RESPONDING AND HE COULD NOT MOVE IT IN ANY DIRECTION. HE STATED THAT THE ARM WAS NOT IN A WEIRD POSITION (FULLY EXTENDED OR FOLDED ON ITSELF) AND THAT THE TELESCOPIC ARM WAS FULLY IN (AT POSITION 0). THE FIELD SERVICE ENGINEER (FSE) ASKED HIM TO DO THE FOLLOWING: - CHANGE THE SPEED BETWEEN FAST AND SLOW AND ATTEMPT TO MOVE - HE SAID THAT THIS DID NOT WORK AND THAT THE ARM WOULD ONLY MOVE IN VERY SMALL STEPS - LOOSEN THE KNURLED SCREWS HOLDING THE POINTER PROBE TO THE INTERFACE BLOCK AND TRY TO MOVE - NO DIFFERENCE - EXIT REGISTRATION AND PUT ROBOT IN FREE AND FAST - NO DIFFERENCE - CHECK THE FORCE SENSOR CABLE CONNECTION - CABLE IS SECURE AND DOES NOT APPEAR TO BE BROKEN AT THIS POINT, THE FSE ASKED THE SURGEON TO RESTART THE SYSTEM TO CLEAR ANY MISCALIBRATION THAT MAY HAVE OCCURRED. THE FSE WAS WORRIED THAT SOMEONE HAD ATTACHED THE POINTER PROBE WHEN NOTHING WAS SUPPOSED TO BE CONNECTED TO THE FORCE SENSOR. AFTER RESTART, THE SURGEON ATTEMPTED TO START MARKERS REGISTRATION WHEN THE ROBOT GAVE HIM A TOOL CALIBRATION ERROR AND HE COULD NOT CONTINUE. AFTER THIS HAPPENED A FEW TIMES, THE FSE ASKED HIM TO CONFIRM THE SERIAL NUMBER, WHICH HE DID, AND THEN TO EXIT MARKERS REGISTRATION. THE FSE ASKED HIM TO TRY THE CONTACTLESS REGISTRATION AND HE ALSO EXPERIENCED A CALIBRATION FAILURE WITH THE DISTANCE SENSOR. AT THIS POINT, THE FSE ASKED HIM TO EXIT THE CURRENT PATIENT FOLDER AND OPEN THE PATIENT FOLDER FROM THIS MORNING AND ATTEMPT TO ENTER GUIDANCE MODE USING THE POINTER PROBE TO DRIVE TO A TRAJECTORY. HE DID THIS WITHOUT A PROBLEM AND ABORTED THE MOVE SINCE A NEW PATIENT WAS ATTACHED TO THE ROBOT. ONCE HE DROVE HOME, THE FSE HAD HIM CLOSE THIS PATIENT FOLDER AND OPEN THE ORIGINAL PATIENT FOLDER FOR THE CURRENT PATIENT. AGAIN, WHEN HE TRIED TO ENTER MARKERS REGISTRATION, THE POINTER PROBE FAILED CALIBRATION. AT THIS POINT ANOTHER FSE ARRIVED AT CUSTOMER SITE TO ASSIST THE SURGEON IN PERSON. THE FSE FIRST TRIED THE POINTER IN KINEVERIF TO SEE IF IT WORKED AND THEN RE-INSTALLED THE DAT FILE FOR KINEVERIF TEST. HE SAID THAT WITHOUT INSTALLING THE NEW DAT FILE, THE POINTER WORKED IN KINEVERIF BUT STILL SHOWED A CALIBRATION ERROR IN ROSANNA. HE THEN INSTALLED THE DAT FILE AND THE POINTER PROBE PASSED CALIBRATION IN ROSANNA BUT EXHIBITED BIZARRE BEHAVIOR. ON THE FIRST ATTEMPT, THE ROBOT DROVE TO INTERMEDIATE POSITION AND THEN STARTED TO RISE. THEY CANCELLED THE REGISTRATION AND THEN RESTARTED IT. ON THE SECOND ATTEMPT, THE ROBOT DID NOT EXHIBIT THIS RISING BEHAVIOR BUT WAS VERY HARD TO CONTROL IN COOPERATIVE MODE. THE FSE DESCRIBED THE ROBOTIC ARM AS FIGHTING BACK AGAINST THE SURGEON NOT MOVING IN THE SAME WAY AS THE SURGEON INTENDED. AT THIS POINT, THE FIRST FSE SPOKE WITH THE SECOND FSE ABOUT POTENTIALLY REINSTALLING THE ROBOT CONTROLLER PROGRAMS. HE LEFT THE ROOM TO GET AN ETHERNET CABLE AND WHEN HE RETURNED THE SURGEON DECIDED TO ABORT THE SURGERY. THE PATIENT CURRENTLY HAS BONE FIDUCIALS IMPLANTED AND THE SURGERY WAS NOT ABLE TO MAKE IT PAST REGISTRATION. THIS IS A PATIENT WITH A PRIOR SEEG THAT WAS HAVING ELECTRODES ADDED FOR FURTHER INVESTIGATION." }, { "mdr_text_key": "312111376", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT THE ROBOT ARM WAS DIFFICULT TO MOVE AND THAT THE DISTANCE SENSOR HAD FAILED THE ACCURACY TESTS. DHR REVIEW AND REVIEW OF COMPLAINT HISTORY DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. ACCORDING TO TECHNICAL INVESTIGATION, THERE WAS A FALSE CONTACT IN THE ATI BOX OF THE FORCE SENSOR (POWER SUPPLY). IN ORDER TO BE ABLE TO PERFORM A SURGERY, THE INTERFACE BLOCK OF BR18049 WAS SWITCHED WITH THE INTERFACE BLOCK OF BR18052. BOTH DEVICES PASSED THE COMPLETE MAINTENANCE THE (B)(6) 2019." }, { "mdr_text_key": "133049434", "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": "133049435", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE SURGEON WAS AT THE REGISTRATION (MARKERS) PHASE OF HIS SECOND SURGERY OF THE DAY AND WAS EXPERIENCING DIFFICULTY MOVING THE ROBOTIC ARM IN COOPERATIVE MODE. HE CLAIMED THAT DURING HIS FIRST SURGERY THIS DAY, THE ROBOTIC ARM WAS VERY HARD TO MOVE AND DID NOT MOVE THE WAY HE INTENDED WHEN USING COOPERATIVE MODE. HE MENTIONED THAT AT ONE POINT, THE ROBOT ARM MOVED WHEN HE STEPPED ON THE PEDAL AND WAS NOT TOUCHING IT. WHILE ON THE PHONE, HE CLAIMED THAT THE ARM WAS NOT RESPONDING AND HE COULD NOT MOVE IT IN ANY DIRECTION. HE STATED THAT THE ARM WAS NOT IN A WEIRD POSITION (FULLY EXTENDED OR FOLDED ON ITSELF) AND THAT THE TELESCOPIC ARM WAS FULLY IN (AT POSITION 0). THE FIELD SERVICE ENGINEER (FSE) ASKED HIM TO DO THE FOLLOWING: CHANGE THE SPEED BETWEEN FAST AND SLOW AND ATTEMPT TO MOVE - HE SAID THAT THIS DID NOT WORK AND THAT THE ARM WOULD ONLY MOVE IN VERY SMALL STEPS. LOOSEN THE KNURLED SCREWS HOLDING THE POINTER PROBE TO THE INTERFACE BLOCK AND TRY TO MOVE - NO DIFFERENCE. EXIT REGISTRATION AND PUT ROBOT IN FREE AND FAST - NO DIFFERENCE. CHECK THE FORCE SENSOR CABLE CONNECTION - CABLE IS SECURE AND DOES NOT APPEAR TO BE BROKEN. AT THIS POINT, THE FSE ASKED THE SURGEON TO RESTART THE SYSTEM TO CLEAR ANY MISCALIBRATION THAT MAY HAVE OCCURRED. THE FSE WAS WORRIED THAT SOMEONE HAD ATTACHED THE POINTER PROBE WHEN NOTHING WAS SUPPOSED TO BE CONNECTED TO THE FORCE SENSOR. AFTER RESTART, THE SURGEON ATTEMPTED TO START MARKERS REGISTRATION WHEN THE ROBOT GAVE HIM A TOOL CALIBRATION ERROR AND HE COULD NOT CONTINUE. AFTER THIS HAPPENED A FEW TIMES, THE FSE ASKED HIM TO CONFIRM THE SERIAL NUMBER, WHICH HE DID, AND THEN TO EXIT MARKERS REGISTRATION. THE FSE ASKED HIM TO TRY THE CONTACTLESS REGISTRATION AND HE ALSO EXPERIENCED A CALIBRATION FAILURE WITH THE DISTANCE SENSOR. AT THIS POINT, THE FSE ASKED HIM TO EXIT THE CURRENT PATIENT FOLDER AND OPEN THE PATIENT FOLDER FROM THIS MORNING AND ATTEMPT TO ENTER GUIDANCE MODE USING THE POINTER PROBE TO DRIVE TO A TRAJECTORY. HE DID THIS WITHOUT A PROBLEM AND ABORTED THE MOVE SINCE A NEW PATIENT WAS ATTACHED TO THE ROBOT. ONCE HE DROVE HOME, THE FSE HAD HIM CLOSE THIS PATIENT FOLDER AND OPEN THE ORIGINAL PATIENT FOLDER FOR THE CURRENT PATIENT. AGAIN, WHEN HE TRIED TO ENTER MARKERS REGISTRATION, THE POINTER PROBE FAILED CALIBRATION. AT THIS POINT, ANOTHER FSE ARRIVED AT CUSTOMER SITE TO ASSIST THE SURGEON IN PERSON. THE FSE FIRST TRIED THE POINTER IN KINEVERIF TO SEE IF IT WORKED AND THEN RE-INSTALLED THE DAT FILE FOR KINEVERIF TEST. HE SAID THAT WITHOUT INSTALLING THE NEW DAT FILE, THE POINTER WORKED IN KINEVERIF BUT STILL SHOWED A CALIBRATION ERROR IN ROSANNA. HE THEN INSTALLED THE DAT FILE AND THE POINTER PROBE PASSED CALIBRATION IN ROSANNA BUT EXHIBITED BIZARRE BEHAVIOR. ON THE FIRST ATTEMPT, THE ROBOT DROVE TO INTERMEDIATE POSITION AND THEN STARTED TO RISE. THEY CANCELLED THE REGISTRATION AND THEN RESTARTED IT. ON THE SECOND ATTEMPT, THE ROBOT DID NOT EXHIBIT THIS RISING BEHAVIOR BUT WAS VERY HARD TO CONTROL IN COOPERATIVE MODE. THE FSE DESCRIBED THE ROBOTIC ARM AS FIGHTING BACK AGAINST THE SURGEON NOT MOVING IN THE SAME WAY AS THE SURGEON INTENDED. AT THIS POINT, THE FIRST FSE SPOKE WITH THE SECOND FSE ABOUT POTENTIALLY REINSTALLING THE ROBOT CONTROLLER PROGRAMS. HE LEFT THE ROOM TO GET AN ETHERNET CABLE AND WHEN HE RETURNED, THE SURGEON DECIDED TO ABORT THE SURGERY. THE PATIENT CURRENTLY HAS BONE FIDUCIALS IMPLANTED AND THE SURGERY WAS NOT ABLE TO MAKE IT PAST REGISTRATION. THIS IS A PATIENT WITH A PRIOR SEEG THAT WAS HAVING ELECTRODES ADDED FOR FURTHER INVESTIGATION." } ], "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": "09/24/2019" } ] }