The workflow files, logs, and patient scans for surgeries on (b)(6) 2017 were obtained and anonymized on (b)(6) 2017.The data were analyzed by a synaptive software developer.In addition, a synaptive representative went to the site to test the equipment.The hardware, software and instruments all passed specifications.The root cause is that inadequate registration was performed by the clinical staff during the procedure (against existing synaptive documentation and software controls).The surgeon also indicated that he was satisfied with the outcome of the second procedure completed using the same system.
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A site representative reported that during the procedure brightmatter guide had led the surgeon to believe that he was at the site of the tumor, so he proceeded with resection.However, post-operative pathology results indicated that the tissue was healthy brain tissue.A second procedure was then scheduled for the patient.Post-operative pathology results indicated that the tissue was grade 1 meningioma.During both procedures, anatomical landmarks were used for registration using the same system.No patient harm, or death was observed during the procedures.
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