Model Number 9733560 |
Device Problem
Human-Device Interface Problem (2949)
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Patient Problem
Therapeutic Response, Decreased (2271)
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Event Date 12/10/2018 |
Event Type
Injury
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Manufacturer Narrative
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A medtronic representative went to the site to test the equipment.Testing revealed that the navigation system functioned as designed.The system then passed the system checkout and was found to be fully functional.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic received information that, while in a functional endoscopic sinus surgery (fess), an imprecision was observed following patient registration and subsequently elected to discontinue with the procedure.It was reported that there were six computed tomography (ct) exams for the patient.It was noted that the site did not select the proper grouping of three exams that included an axial exam with appropriate slice thickness.It was reported the site used a coronal exam with a lower slice count and 2-3millimeter slick thickness.Following the procedure, a separate procedure with the same navigation system was performed on a separate patient without issue.There was a reported delay to the procedure of less than 1 hour due to this issue.No additional information was provided.
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Manufacturer Narrative
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The total inaccuracy of the event was 5 mm.A review of the archives found no registrations present on archive.Two of the exams were axial and to protocol.There was also a coronal and sagittal, both with top, sides, and back of the head cut off.All exams loaded 3d models as blocks.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Software analysis was initiated to determine the cause of the issue.It was confirmed that the behavior described is the intended behavior of the software.Software is functioning as designed.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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