{ "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. (B)(4)." }, { "mdr_text_key": "192629168", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "SURGEON PERFORMED CONTACT-LESS REGISTRATION USING CT. FIRST INSTANCE ERROR REPORTED INSUFFICIENT ACCURACY. SECOND INSTANCE WAS ALSO INACCURATE. THIRD WAS SUCCESSFUL AND SHOWED ADEQUATE ACCURACY DURING VERIFICATION. DELAY OF 30 MINUTES DUE TO REPEATED REGISTRATION ATTEMPTS. SEEG SURGERY, NO INCISION MADE." }, { "mdr_text_key": "319584759", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DEVICE HISTORY RECORD REVIEW AND COMPLAINT HISTORY REVIEW DID NOT IDENTIFY CONTRIBUTING FACTORS. A FULL ANALYSIS OF THE DATA LOGS AND OF THE PATIENT FOLDER HAS BEEN PERFORMED. THIS ANALYSIS CONCLUDED THAT THE INACCURACY OF THE FIRST TWO REGISTRATIONS IS DUE TO THE DIFFERENCE IN SKIN SURFACE BETWEEN THE PREOPERATIVE CT AND THE PATIENT AT THE TIME OF THE OPERATION. LASER REGISTRATION IS MORE DIFFICULT TO ACHIEVE WHEN THE PATIENT¿S SKIN IS SUBJECT TO DEFORMATION. THE USER CONTINUED THE OPERATION ONCE THE REGISTRATION WAS PROPERLY COMPLETED. THERE WAS NO FAILURE DETECTED, THE ROSA ONE DEVICE OPERATED WITHIN SPECIFICATION." }, { "mdr_text_key": "319584760", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "SURGEON PERFORMED CONTACT-LESS REGISTRATION USING CT. FIRST INSTANCE ERROR REPORTED INSUFFICIENT ACCURACY. SECOND INSTANCE WAS ALSO INACCURATE. THIRD WAS SUCCESSFUL AND SHOWED ADEQUATE ACCURACY DURING VERIFICATION. DELAY OF 30 MINUTES DUE TO REPEATED REGISTRATION ATTEMPTS. SEEG SURGERY, NO INCISION MADE." } ], "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": "08/21/2020" } ] }