Patient weight refused to be provided by the site.A medtronic representative reported that this site uses an advanced diagnostic group (archives) for imaging, where the portion of the head is on different studies (not complete head on one).When it is re-archived they somehow get the complete head.A medtronic representative went to the site to test the equipment.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.The software archive was deleted and unavailable for evaluation.The software logs were reviewed but these type of logs do not contain information necessary to evaluate alleged inaccuracy.The software investigation found that a cause was unable to be determined without further information since the on-going investigation proved to be inconclusive based on the information provided.Per the reported event the most likely cause was that the images were not to protocol as the top part of the head was not contained on the first study and was split onto another study.The instructions for use (ifu) which accompanies the device contains guidance and instructions regarding proper imaging protocols for cranial, dbs, spine, and ent applications.
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A medtronic representative reported that when he entered the or the surgeon gave him a cd with the patient's ct images.The rep loaded it into the navigation system and noticed that the majority of the scan was on one study and the top of the head was on a different study.He told the surgeon that he did not think that the scan would work with the navigation system and that it would not be able to register the patient.The surgeon requested that the rep try and merge the studies together.The rep was able to manually merge the studies but they were not a perfect match so the surgeon also tried to merge them.The rep made it clear to the surgeon that the merge was not working and that he did not advise registration.The surgeon agreed to try it and was able to get the merge to register.After the functional endoscopic sinus surgery (fess) procedure had started the navigation system seemed to be working fine.The lower half of the scan seemed to be accurate but the top part of the scan above the merge was several mm off.The surgeon was aware that the navigation was not accurate and he made a point to show the rep how far off it was.The rep had to leave about 10 minutes before the surgery was finished.However, a second rep was present for the completion of the procedure and was unaware of any complications.The second rep packed up the navigation system and left the site.Approximately, a month later the reps were informed that the patient had an eye injury as a result of this procedure and required a second surgery at another facility to improve symptoms.
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