Model Number ROSA ONE 3.1 |
Device Problem
Program or Algorithm Execution Failure (4036)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/13/2022 |
Event Type
malfunction
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Manufacturer Narrative
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A full analysis of the data logs has been performed and concluded that rms values superior to 4mm were systematically obtained during the case.This was due to the pointer probe used, that was found non-compliant during later maintenance tests due to a deformation of the tip of the pointer probe.Udi#: (b)(4).
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Event Description
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The customer reported that the registration both with frame and fiducials does not work.The result is a rms superior to 4 mm which is superior to specifications.The system is currently not working, surgery had to be aborted and rescheduled.
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Search Alerts/Recalls
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