Model Number ROSA ONE |
Device Problem
Unintended Collision (1429)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/02/2020 |
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.Udi# : (b)(4).
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Event Description
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During bone fiducial registration using leksell frame pins, pointer probe became stuck in position inside the right posterior leksell frame pin.Upon attempt to move from stuck location, emergency shutdown occurred.Patient was anesthetized during this error and successful registration followed power cycle.Delayed surgery 10 minutes.
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Manufacturer Narrative
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A full analysis of the data logs has been performed and led to the following observations : the user was unable to move the robot arm from the leksell frame pin due to a known software anomaly that can occur when contact is made between an instrument and a surface in cooperative fast mode.The subsequent system shutdown observed most probably results from an excessive force detected in one of the arm joints, but this could not be verified in the controller logs due to a controller malfunction.Upon restart, the user was able to clear the robot arm and to resume the procedure successfully.
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Event Description
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During bone fiducial registration using leksell frame pins, pointer probe became stuck in position inside the right posterior leksell frame pin.Upon attempt to move from stuck location, emergency shutdown occurred.Patient was anesthetized during this error and successful registration followed power cycle.Delayed surgery 10 minutes.
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Search Alerts/Recalls
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