{ "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": "3009185973-2019-00147", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20190423", "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": "20190423", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "332770", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190423", "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": "", "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": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250825", "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": "20190423", "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": "20190423", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8540236", "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": "142774655", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THREE DIFFERENT ISSUES WERE REPORTED. FIRSTLY THE MERGE WAS UNSUCCESSFUL. SECONDLY A COMMUNICATION FAILURE OCCURRED AND THE ROBOT HAD TO BE RESTARTED. THE ROBOT ARM WAS IN THE \"HOME\" POSITION WHEN THIS OCCURRED. LATER ON, THE ROBOT SHUT DOWN NORMALLY BUT WITH THE ROBOT ARM STILL IN THE \"HOME\" POSITION. EVENT SUMMARY, DEVICE HISTORY RECORD REVIEW AND COMPLAINT HISTORY REVIEW DID NOT IDENTIFY CONTRIBUTING FACTORS. THE TECHNICAL INVESTIGATION INDICATED THAT THE MERGE SHOULD HAVE BEEN ADJUSTED, INDEED A WINDOW IS DISPLAYED THAT ALLOWS A USER VERIFICATION OF THE FUSION QUALITY AND PERFORMING A FINAL FINE ADJUSTMENT, IF NECESSARY. AS THE USER MANUAL PROVIDE ALL NECESSARY INFORMATION CONCERNING THE FUSION ADJUSTMENT, THIS ISSUE CAN BE CONSIDERED AS A USE ERROR. THE COMMUNICATION ERROR WAS FOUND TO BE DUE TO A SHARED MEMORY ISSUE. THE FACT THAT THE ROBOT ARM STAYED IN HOME INSTEAD OF GOING TO PARKING POSITION IS AN EXPECTED BEHAVIOR OF THE DEVICE, NO MALFUNCTION OCCURRED. UNIQUE IDENTIFIER (UDI) #: (B)(4)." }, { "mdr_text_key": "142774656", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT THE SURGEON DECIDED TO USE BONE FIDUCIALS FOR PATIENT REGISTRATION. SIX BONE FIDUCIALS WERE INSERTED TO THE PATIENT'S SKULL, AND THEN THE PATIENT WAS TAKEN AWAY FROM THE OR TO GET A CT SCAN DONE WITH THE FIDUCIALS INSERTED. AFTER UPLOADING THE IMAGES, THE FIELD SERVICE ENGINEER NOTICED THERE WERE MORE THAN THE 255 MAXIMUM NUMBER OF SLICES IN THE IMAGE SET. THE FSE REMOVED ENOUGH SLICES FROM THE IMAGE SET (REMOVED SLICES BELOW THE NOSE) AND ATTEMPTED TO MERGE THAT SCAN TO THE CUT-OFF PRE-OP CTA SCAN. THE MERGE WAS UNSUCCESSFUL. THE FSE NOTIFIED THE SURGEON THAT THE MOST LIKELY REASON FOR THE FAILURE IS THAT THE SCAN BEING MERGED TO IS CUT OFF AT THE NOSE. THE FSE ATTEMPTED TO MERGE THE BONE FIDUCIAL CT TO ONE OF THE PRE-OP MR SCANS THAT WERE ALREADY UPLOADED, AND THE MERGE APPEARED TO BE SUCCESSFUL TO THE MR SCAN (MR SCAN WAS NOT CUT AT THE NOSE). AFTER ACCEPTING THIS MERGE, THE PRE-OP CTA AND NEWLY MERGED BONE FIDUCIAL CT WERE COMPARED TO SEE IF THEY OVERLAYED CORRECTLY. THERE WAS A NOTICEABLE DIFFERENCE BETWEEN THE TWO SCANS, WHERE ONE WAS SHIFTED A MM OR SO FROM THE OTHER. THE FSE AND SURGEON BOTH DECIDED THIS MERGE WAS NOT CORRECT. THE FSE ATTEMPTED TO PERFORM A SEMI-AUTOMATIC MERGE, BUT AFTER SELECTING ABOUT SEVEN POINTS ON EACH SCAN, A COMMUNICATION FAILURE OCCURRED SUDDENLY AND THE ROBOT HAD TO BE RESTARTED. THE ROBOT ARM WAS CURRENTLY IN THE \"HOME\" POSITION WHEN THIS OCCURRED. AFTER THE ROBOT WAS REBOOTED, THE MERGE WAS ATTEMPTED AGAIN BUT THE SAME RESULT WAS OCCURRING. THE SURGEON STATED THAT THEY DID NOT WANT TO TRY AND MERGE THE BONE FIDUCIAL CT MANUALLY, SINCE THEY DID NOT TRUST THEMSELVES GETTING IT PERFECTLY CORRECT. THE FSE AND SURGEON WENT OVER ALL OF THE AVAILABLE OPTIONS FOR MOVING FORWARD WITH THE CASE. THE SURGEON DECIDED THAT THE SAFEST ROUTE WOULD BE TO RESCHEDULE THE SURGERY, AND OBTAIN A NEW CT SCAN WITH THE NOSE INCLUDED. THE FSE EXITED OUT OF THE CASE ON THE SOFTWARE, AND SELECTED THE OPTION TO SHUT DOWN THE ROBOT. THE SOFTWARE DID NOT ASK TO SEND THE ROBOT ARM TO THE PARKED POSITION, AND INSTEAD THE ROBOT SHUT DOWN NORMALLY BUT WITH THE ARM STILL IN THE \"HOME\" POSITION. THE ARM WAS NEVER MOVED AFTER THE COMMUNICATION FAILURE OCCURRED DURING THE SEMI-AUTOMATIC MERGE ATTEMPT, SO THIS MOST LIKELY RESULTED IN THIS ISSUE. THE ROBOT WAS TURNED ON AGAIN AND THE ARM WAS MOVED TO THE PARKED POSITION. THE TOTAL TIME IT TOOK TO GET THE BONE FIDUCIAL SCAN AND ATTEMPTING TO MERGE WAS AROUND TWO HOURS. THE CASE WAS EVENTUALLY ABORTED AND 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": "" } ] }