{ "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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BASED ON THE AVAILABLE INFORMATION THE MOST PROBABLE ROOT CAUSE IS COMPROMISED REGISTRATION ACCURACY DUE TO REDUCED SCANNING AREA ON THE FOREHEAD BECAUSE OF USER ERROR, HEAD MOVEMENT DURING SURGERY AND UNCLEAR IFU REGARDING WHEN TO REPERFORM REGISTRATION BASED ON REGISTRATION VERIFICATION RESULTS. UPDATED AS PER INVESTIGATION CONCLUSIONS. DATE RECEIVED BY MANUFACTURER - UPDATED WITH DATE OF INVESTIGATION COMPLETION." }, { "mdr_text_key": "89136935", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION WILL BE PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. (B)(4). IT WAS REPORTED THAT THERE WAS A DELAY OVER 30 MINUTES ON THE SURGERY DUE TO THE REPORTED EVENT. 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