{ "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": "3009185973-2019-00146", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20190419", "manufacturer_address_2": "", "pma_pmn_number": "K172444", "date_of_event": "20190325", "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": "20190419", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "326440", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190419", "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": "ROSAS00303", "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", "Computer Software Problem" ], "reporter_state_code": "MI", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/19/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250731", "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": "20190419", "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": "20200525", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8530842", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20190325", "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": "316581498", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS NOTED BY THE FIELD SERVICE ENGINEER (FSE) THAT THE PRE-OP EXAM THAT WAS GOING TO BE USED WAS CUT OFF JUST BELOW THE PATIENT'S EYE LIDS, CUTTING OFF MOST OF THE NOSE. THE FSE NOTIFIED THE SURGEON AND EXPLAINED THAT THIS MAY CAUSE AN ISSUE WITH THE REGISTRATION AND VERIFICATION, SINCE THE ACQUISITION PROTOCOL STATES THAT THE NOSE NEEDS TO BE INCLUDED FOR LASER REGISTRATION. THE SURGEON DID NOT HAVE ANOTHER SCAN TO USE, AND WANTED TO GIVE THE REGISTRATION A TRY WITH THE CUT OFF SCAN. DURING REGISTRATION, THE SURGEON MADE SURE TO STAY ABOVE THE PORTION WHERE THE SCAN WAS CUT OFF, AND THE FSE DID NOT NOTICE ANY ERRORS. THE LASER REGISTRATION VERIFICATION SEEMED TO HAVE PASSED AFTER CHECKING THE INITIAL 7 POINTS ON THE FRONT OF THE PATIENT'S FACE. THE LASER WAS THEN BROUGHT TOWARDS THE BACK OF THE PATIENT'S SKULL TO VERIFY THE REGISTRATION WHERE THE TRAJECTORIES WERE BEING PLACED. THE FSE NOTICED THAT THE LASER MARKER FOR VERIFICATION WAS AROUND 4MM OFF THE SKIN OF THE SKULL ON THE SOFTWARE. THE AREA THAT WAS CHECKED HAD BEEN SHAVEN, AND THERE WAS NO HAIR THAT APPEARED TO BE INTERFERING WITH THE LASER. OTHER POINTS ON THE SKULL WERE CHECKED AND GAVE SIMILAR RESULTS, SHOWING THAT THE LASER MARKER ON THE SOFTWARE WAS ANY WHERE FROM 2MM TO 5MM OFF THE SKIN. THE POINTER PROBE WAS THEN SWITCHED WITH THE LASER TO CHECK AND SEE IF THE SAME RESULTS OCCURRED. THE POINTER PROBE WAS BROUGHT TO THE SURFACE OF THE SKIN, AND THE SOFTWARE AGAIN SHOWED THAT THE TIP OF THE PROBE WAS OFF OF THE SKIN ANYWHERE BETWEEN 2MM-5MM DEPENDING ON WHERE IT WAS ON THE PATIENT'S SKULL. THE LASER AND POINTER ALSO WERE BROUGHT BACK TO THE PATIENT'S FACE TO RE-CHECK THOSE POINTS, AND ALL OF THE POINTS ON THE FACE APPEARED TO STILL BE CORRECT. THE FSE DID NOT NOTICE ANY OTHER POSSIBLE ERRORS, OTHER THAN THE CUT OFF SCAN POSSIBLY CAUSING THE ISSUE WITH REGISTRATION. THE LASER REGISTRATION WAS ONLY PERFORMED THE ONE TIME. AFTER CHECKING THE VERIFICATION WITH THE LASER AND POINTER NUMEROUS TIMES, THE DELAY WAS AROUND 30 MINUTES. THE CASE WAS EVENTUALLY ABORTED AND WILL BE RE-SCHEDULED." }, { "mdr_text_key": "316581499", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT THE LASER REGISTRATION VERIFICATION SEEMED TO BE ACCURATE ON POINTS ON THE PATIENT¿S FACE AND INACCURATE ON THE BACK OF THE PATIENT¿S SKULL. THE LASER AND POINTER PROBE MARKERS APPEARED ON THE SURFACE OF THE FACIAL SKIN WHEN THEY APPEARED ABOVE THE 3D REPRESENTATION OF THE SKIN AT THE BACK OF THE SKULL. THIS ISSUE CAN BE EXPLAINED BY THE THICKNESS OF THE SKIN, WHICH MAY VARY. IT WAS PROBABLY FINER WHEN THE CT WAS ACQUIRED THAN ON THE DAY OF THE SURGERY. AS NOT ENOUGH ELEMENTS ARE PROVIDED IN DATA AVAILABLE ON NETWORK TO CONFIRM THIS POSSIBLE CAUSE, THE ROOT CAUSE FOR THIS ISSUE CANNOT BE DETERMINED. A DHR REVIEW AND A REVIEW OF COMPLAINT HISTORY DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. CORRECTED DATA: B4 DATE OF THIS REPORT. D4 CATALOG NUMBER. G4 DATE RECEIVED BY MANUFACTURER. H2 IF FOLLOW-UP, WHAT TYPE. H3 DEVICE EVALUATED BY MANUFACTURER. H6 EVENT PROBLEM AND EVALUATION CODES. H10 ADDITIONAL NARRATIVES/DATA." }, { "mdr_text_key": "142464025", "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": "142464026", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS NOTED BY THE FIELD SERVICE ENGINEER (FSE) THAT THE PRE-OP EXAM THAT WAS GOING TO BE USED WAS CUT OFF JUST BELOW THE PATIENT'S EYE LIDS, CUTTING OFF MOST OF THE NOSE. THE FSE NOTIFIED THE SURGEON AND EXPLAINED THAT THIS MAY CAUSE AN ISSUE WITH THE REGISTRATION AND VERIFICATION, SINCE THE ACQUISITION PROTOCOL STATES THAT THE NOSE NEEDS TO BE INCLUDED FOR LASER REGISTRATION. THE SURGEON DID NOT HAVE ANOTHER SCAN TO USE, AND WANTED TO GIVE THE REGISTRATION A TRY WITH THE CUT OFF SCAN. DURING REGISTRATION, THE SURGEON MADE SURE TO STAY ABOVE THE PORTION WHERE THE SCAN WAS CUT OFF, AND THE FSE DID NOT NOTICE ANY ERRORS. THE LASER REGISTRATION VERIFICATION SEEMED TO HAVE PASSED AFTER CHECKING THE INITIAL 7 POINTS ON THE FRONT OF THE PATIENT'S FACE. THE LASER WAS THEN BROUGHT TOWARDS THE BACK OF THE PATIENT'S SKULL TO VERIFY THE REGISTRATION WHERE THE TRAJECTORIES WERE BEING PLACED. THE FSE NOTICED THAT THE LASER MARKER FOR VERIFICATION WAS AROUND 4MM OFF THE SKIN OF THE SKULL ON THE SOFTWARE. THE AREA THAT WAS CHECKED HAD BEEN SHAVEN, AND THERE WAS NO HAIR THAT APPEARED TO BE INTERFERING WITH THE LASER. OTHER POINTS ON THE SKULL WERE CHECKED AND GAVE SIMILAR RESULTS, SHOWING THAT THE LASER MARKER ON THE SOFTWARE WAS ANY WHERE FROM 2MM TO 5MM OFF THE SKIN. THE POINTER PROBE WAS THEN SWITCHED WITH THE LASER TO CHECK AND SEE IF THE SAME RESULTS OCCURRED. THE POINTER PROBE WAS BROUGHT TO THE SURFACE OF THE SKIN, AND THE SOFTWARE AGAIN SHOWED THAT THE TIP OF THE PROBE WAS OFF OF THE SKIN ANYWHERE BETWEEN 2MM-5MM DEPENDING ON WHERE IT WAS ON THE PATIENT'S SKULL. THE LASER AND POINTER ALSO WERE BROUGHT BACK TO THE PATIENT'S FACE TO RE-CHECK THOSE POINTS, AND ALL OF THE POINTS ON THE FACE APPEARED TO STILL BE CORRECT. THE FSE DID NOT NOTICE ANY OTHER POSSIBLE ERRORS, OTHER THAN THE CUT OFF SCAN POSSIBLY CAUSING THE ISSUE WITH REGISTRATION. THE LASER REGISTRATION WAS ONLY PERFORMED THE ONE TIME. AFTER CHECKING THE VERIFICATION WITH THE LASER AND POINTER NUMEROUS TIMES, THE DELAY WAS AROUND 30 MINUTES. THE CASE WAS EVENTUALLY ABORTED AND WILL BE RE-SCHEDULED." } ], "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": "05/25/2020" } ] }