Model Number ROSA ONE 3.1 |
Device Problem
Image Display Error/Artifact (1304)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/03/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The device has not been evaluated yet for investigation purpose.Once the evaluation is performed, a follow-up medwatch report will be submitted.Unique identifier (udi) #: (b)(4).
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Event Description
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The clinical representative (cr) was present for an seeg case.After placing the electrodes, the surgeon had an intraoperative ct taken to confirm accuracy using the airo.The airo scan did not merge correctly with the automatic merge on the first try.The surgeon had to try to recalculate the merge several times before the rosa software was able to correctly merge the two scans.No delay to case, after first incision, patient was already under anesthesia, no patient impact.
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Event Description
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The clinical representative (cr) was present for an seeg case.After placing the electrodes, the surgeon had an intraoperative ct taken to confirm accuracy using the airo.The airo scan did not merge correctly with the automatic merge on the first try.The surgeon had to try to recalculate the merge several times before the rosa software was able to correctly merge the two scans.No delay to case, after first incision, patient was already under anesthesia, no patient impact.
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Manufacturer Narrative
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A full analysis of the data logs has been performed and this analysis concluded that the 'recalculate' function was pressed several times before achieving satisfying results, but the use of this function along with manual adjustments is a normal behavior when the automatic fusion does not give satisfying results.There was no failure detected, the device operated within specification.
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Search Alerts/Recalls
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