Model Number ROSA ONE 3.1 |
Device Problem
Application Program Problem (2880)
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Patient Problem
No Patient Involvement (2645)
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Event Date 02/12/2021 |
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 in (b)(6) for the spine applicative training.When start the rosa robot, the system brought up an robotic error.System had to be shut down.The cr powered the system of for about 60 secs.The next start was successful.The cr went through the setup procedure and the ziehm imaging system told he is ready for the scan.The cr started the countdown for image acquisition.The ziehm brought up a collision warning.The ziehm and table had to be repositioned.The cr tried to abort image transfer, but system froze and had to be restarted.After restart, system when through robot camera registration again, which had been done successful before.Next attempt transfer worked.
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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 arm failed to connect twice due to a communication failure between the robotic software and the robot arm controller.This issue will be addressed through the continuous improvement process of our products.Two software unexpected interruption were detected and required software restart.One was due to a system freeze and the other due to the application software freeze.The cause for those errors cannot be determined.
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Event Description
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The clinical representative (cr) was in university frankfurt for the spine applicative training.When start the rosa robot, the system brought up an robotic error.System had to be shut down.The cr powered the system of for about 60 secs.The next start was successful.The cr went through the setup procedure and the ziehm imaging system told he is ready for the scan.The cr started the countdown for image aquisition.The ziehm brought up a collision warning.The ziehm and table had to be repositioned.The cr tried to abort image transfer, but system froze and had to be restarted.After restart, system when through robot camera registration again, which had been done successful before.Next attempt tranfer worked.
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Search Alerts/Recalls
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