Model Number ROSA ONE 3.1 |
Device Problems
Computer Software Problem (1112); Unintended Collision (1429)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/27/2022 |
Event Type
malfunction
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Event Description
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Robot arm collided against robotic base when orienting itself for trajectory 5.Robot did not prompt the trajectory was inaccessible with the microdrive holder.All trajectories were edited after contactless registration.After restarting the system, clinical representative (cr) was able to clear the robotic arm.However, after the shutdown, during the vigilance device error message, 'clear robot arm' choice prompted an empty calibration.Cr recognized this as the software¿s field action events.To clear the robot, cr drove the robot home.
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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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Manufacturer Narrative
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Dhr review and review of complaint history did not identify any contributory factors to the event.A full analysis of the data logs has been performed and concluded that the first device restart was due to a collision of the arm which provoked the detection of an over force.The collision could have been avoided by releasing the vigilance device.After restart, the arm empty calibration was requested when the arm was still navigated with a tool installed.This is a known software anomaly that was escalated as a field action zfa-2021-00198, fda reference z-0118-2022.
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Event Description
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Robot arm collided against robotic base when orienting itself for trajectory 5.Robot did not prompt the trajectory was inaccessible with the microdrive holder.All trajectories were edited after contactless registration.After restarting the system, clinical representative (cr) was able to clear the robotic arm.However, after the shutdown, during the vigilance device error message, 'clear robot arm' choice prompted an empty calibration.Cr recognized this as the software¿s field action events.To clear the robot, cr drove the robot home.
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Search Alerts/Recalls
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