{ "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. 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ONCE THE EVALUATION IS PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. UNIQUE IDENTIFIER (UDI) #: (B)(4)." }, { "mdr_text_key": "209385225", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "COMPANY CLINICAL REPRESENTATIVE (CR) WAS ASSISTING FOR TWO ABLATION CASES. ONCE THE SECOND CASE BEGAN, ONCE AGAIN THE MERGE OF THE NEWLY ACQUIRED CT EXAM TO THE MR LOOKED GOOD AND ACCEPTABLE. HOWEVER, ONCE THE FIDUCIAL REGISTRATION PROCESS BEGAN, IT WAS VERY APPARENT THAT THE CT AND MR WERE NOT MATCHED UP. ALTHOUGH A POINT LOOKED GOOD ON THE CT, THE MR WAS SHOWING THAT THE POINT WAS AT LEAST 5MM DEEPER, INDICATING ONCE AGAIN THAT THE MERGE WAS NOT LINED UP. DUE TO CONCERN WITH THE SURGEON, THE CASE WAS ABORTED AS TO AVOID ANY INACCURACY FOR THE PATIENT. THEY HAVE HAD 3 CASES IN THE PAST MONTH WHERE THE MERGE WAS GOOD AND ACCURACY WAS SPOT-ON. THIS ISSUE SEEMS TO BE CORRELATED WITH THE NEW MERGE PROCESS. THE ROBOT WILL NOT BE USED AT THE HOSPITAL UNTIL THIS IS RESOLVED." }, { "mdr_text_key": "321192301", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A FULL ANALYSIS OF THE LOGS AND OF THE PATIENT FOLDER HAS BEEN PERFORMED. REGARDING THE ANALYSIS, THE MERGE ISSUE IS DUE TO THE INSUFFICIENTLY ACCURATE MERGE OF THE MRI USED FOR THE PLANNING OF THE TRAJECTORIES WITH THE CT-SCAN OF THE FIDUCIAL REGISTRATION. NO ADJUSTMENTS WERE MADE AFTER THE AUTOMATIC MERGE ALTHOUGH THERE WAS A SHIFT AND A ROTATION BETWEEN THE 2 EXAMS. THE USER ABORTED THE SURGERY AFTER HE SAW THAT THE TWO EXAMS DID NOT MATCH. THIS ISSUE COULD HAVE BEEN AVOIDED BY PERFORMING MANUAL ADJUSTMENTS AS RECOMMENDED IN THE USER MANUAL." }, { "mdr_text_key": "321192302", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "COMPANY CLINICAL REPRESENTATIVE (CR) WAS ASSISTING FOR TWO ABLATION CASES. ONCE THE SECOND CASE BEGAN, ONCE AGAIN THE MERGE OF THE NEWLY ACQUIRED CT EXAM TO THE MR LOOKED GOOD AND ACCEPTABLE. HOWEVER, ONCE THE FIDUCIAL REGISTRATION PROCESS BEGAN, IT WAS VERY APPARENT THAT THE CT AND MR WERE NOT MATCHED UP. ALTHOUGH A POINT LOOKED GOOD ON THE CT, THE MR WAS SHOWING THAT THE POINT WAS AT LEAST 5MM DEEPER, INDICATING ONCE AGAIN THAT THE MERGE WAS NOT LINED UP. DUE TO CONCERN WITH THE SURGEON, THE CASE WAS ABORTED AS TO AVOID ANY INACCURACY FOR THE PATIENT. THEY HAVE HAD 3 CASES IN THE PAST MONTH WHERE THE MERGE WAS GOOD AND ACCURACY WAS SPOT-ON. THIS ISSUE SEEMS TO BE CORRELATED WITH THE NEW MERGE PROCESS. THE ROBOT WILL NOT BE USED AT THE HOSPITAL UNTIL THIS IS RESOLVED." } ], "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": "10/27/2020" } ] }