{ "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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THE MERGE BETWEEN THE O-ARM SPIN AND THE T1 MRI WAS UNSUCCESSFUL (AND NECESSARY FOR MARKER REGISTRATION). THE SURGEON WAS NOT ABLE TO MANUALLY ADJUST THE MERGE IN A SATISFACTORY MANNER AND ABANDONED THE USE OF ROSA FOR THIS PROCEDURE, CHOOSING INSTEAD TO USE A CRW FRAME. THE IMPACT TO THE SURGERY WAS A DELAY OF ABOUT 25 MINUTES DUE TO THE TIME WASTED TO SET UP THE ROSA AND RETRIEVE THE CRW." }, { "mdr_text_key": "325688222", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DHR REVIEW AND REVIEW OF COMPLAINT HISTORY DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. A FULL ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED AND THIS ANALYSIS SHOWS THAT THE AUTOMATIC MERGE WAS OFF BEFORE MANUAL ADJUSTMENTS. A TEST WAS PERFORMED ON SIMULATOR AND SHOWED THAT MANUAL ADJUSTMENTS COULD BE PERFORMED IN ORDER TO IMPROVE THE MERGE. NO DEVICE FAILURE WAS DETECTED. HOWEVER, THE ACCEPTANCE OF THE MERGE IS THE SURGEON¿S DECISION." }, { "mdr_text_key": "257395236", "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": "257395237", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT THE FOLLOWING OCCURRED AT AN INDEPENDENT SITE DURING AN ABLATION PROCEDURE WHERE NO CLINICAL REPRESENTATIVE WAS PRESENT. THE MERGE BETWEEN THE O-ARM SPIN AND THE T1 MRI WAS UNSUCCESSFUL (AND NECESSARY FOR MARKER REGISTRATION). THE SURGEON WAS NOT ABLE TO MANUALLY ADJUST THE MERGE IN A SATISFACTORY MANNER AND ABANDONED THE USE OF ROSA FOR THIS PROCEDURE, CHOOSING INSTEAD TO USE A CRW FRAME. THE IMPACT TO THE SURGERY WAS A DELAY OF ABOUT 25 MINUTES DUE TO THE TIME WASTED TO SET UP THE ROSA AND RETRIEVE THE CRW." } ], "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": "07/16/2021" } ] }