Model Number ROSA ONE |
Device Problem
Unintended Movement (3026)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/13/2020 |
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.Unique identifier (udi) #: (b)(4).
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Event Description
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Robot was driving to a trajectory when surgeon requested to stop and move back to park position.Vigilance pedal was released, clear robot arm was selected and then 'free and fast' selected.Upon pressing the vigilance device, robot arm continued to move toward trajectory instead of 'free and fast'.Movement was allowed to complete and then movement back to intermediate position was selected and performed.No errors were signaled in software and surgery continued without any adverse affects.
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Manufacturer Narrative
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A full analysis of the data logs has been performed as well as tests performed on a rosa one system at the manufacturing site, which confirmed the reported issue.Indeed, an unexpected automatic movement occurs when the pedal is depressed and when cooperative mode is selected to clear the arm in a specific workflow.During and after that unexpected move, the cooperative mode is still active and the arm can still be cleared as intended.No adverse event occurred, and in case such event were to recur, clearing the arm (cooperative mode) or releasing the vigilance device pedal would allow the user to avoid any unwanted movement.
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Event Description
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Robot was driving to a trajectory when surgeon requested to stop and move back to park position.Vigilance pedal was released, clear robot arm was selected and then 'free and fast' selected.Upon pressing the vigilance device, robot arm continued to move toward trajectory instead of 'free and fast'.Movement was allowed to complete and then movement back to intermediate position was selected and performed.No errors were signaled in software and surgery continued without any adverse affects.
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Event Description
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Robot was driving to a trajectory when surgeon requested to stop and move back to park position.Vigilance pedal was released, clear robot arm was selected and then 'free and fast' selected.Upon pressing the vigilance device, robot arm continued to move toward trajectory instead of 'free and fast'.Movement was allowed to complete and then movement back to intermediate position was selected and performed.No errors were signaled in software and surgery continued without any adverse affects.
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Manufacturer Narrative
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Additional information was received in which provided clarification that no product malfunction occurred.It was initially reported there was an unexpected movement of the robot arm in cooperative mode when the pedal was depressed; however, this was a misinterpretation of a normal behavior of the system.Additional information received on (b)(6) 2020 revealed that no malfunction or patient harm occurred, and that the circumstances of the event initially described resulted from a misinterpretation of a normal behavior of the system.When the user decided to cancel the current robot movement and selected a new trajectory, the reporter expected the robot arm to return to the ''home'' position after having reached the ''intermediate'' position.However, this expectation is not the behavior specified for the system in such case.The normal workflow specified when a new trajectory is selected is as follows: the cooperative mode is activated to permit the clearance of the robot arm from the patient¿s head then, the robot arm automatically reaches the ''intermediate'' position finally, the robot arm moves towards the selected trajectory - after the validation of the tool orientation.Because the reporter was mistakenly expecting the robot to move to the ''home'' position prior to moving towards the selected trajectory, the subject complaint was opened however; no malfunction actually occurred.Corrected data: b4 date of this report.G4 date received by manufacturer.H2 if follow-up, what type.H3 device evaluated by manufacturer.H6 event problem and evaluation codes.H10 additional narratives/data.
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Search Alerts/Recalls
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