{ "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. UDI# : (B)(4)." }, { "mdr_text_key": "199846583", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "PATIENT FOLDER LOADED IN ON ACCIDENTAL OVERWRITE FROM USB DRIVE RATHER THAN FROM ROSA MEMORY. THIS CAUSED CHANGES TO THE ORIGINAL PLANNING TO BE DELETED AND CAUSE THE SURGEON TO HAVE TO RE-MAKE THE CHANGES MADE PRIOR TO THE BEGINNING OF SURGERY - DONE ON ROSA. ATTEMPTED TO FIND ARCHIVED FILES IN THE MAINTENANCE SIDE, BUT NO FILES REMAINED FROM THE OVERWRITTEN PLAN. PATIENT WAS ALREADY UNDER ANESTHESIA AND CAUSED A 45 MINUTE DELAY IN THE SURGERY." }, { "mdr_text_key": "319861277", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A FULL ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED AND CONCLUDED THAT THE USER LOADED THE PATIENT FOLDER FROM THE USB DEVICE INSTEAD OF THE ROSA MEMORY, AND CONSEQUENTLY ERASED THE FOLDER THAT HE HAD MODIFIED FOR THE PLANNING. DELETING THE EXISTING FOLDER WHEN THE USER CHOOSES TO OVERWRITE IT IS A NORMAL BEHAVIOR OF THE DEVICE. ADEQUATE MESSAGES WERE DISPLAYED TO THE USER (\"THIS PATIENT FOLDER ALREADY EXISTS. DO YOU WANT TO OVERWRITE IT?\"). THE USER MANUAL PROVIDES THE NECESSARY INFORMATION TO DISTINGUISH BETWEEN THE EXTERNAL DEVICE AND THE COMPUTER DEVICE." }, { "mdr_text_key": "319861278", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "PATIENT FOLDER LOADED IN ON ACCIDENTAL OVERWRITE FROM USB DRIVE RATHER THAN FROM ROSA MEMORY. THIS CAUSED CHANGES TO THE ORIGINAL PLANNING TO BE DELETED AND CAUSE THE SURGEON TO HAVE TO RE-MAKE THE CHANGES MADE PRIOR TO THE BEGINNING OF SURGERY - DONE ON ROSA. ATTEMPTED TO FIND ARCHIVED FILES IN THE MAINTENANCE SIDE, BUT NO FILES REMAINED FROM THE OVERWRITTEN PLAN. PATIENT WAS ALREADY UNDER ANESTHESIA AND CAUSED A 45 MINUTE DELAY IN THE SURGERY." } ], "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": "09/08/2020" } ] }