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 01/07/2020 |
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.(b)(4).
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Event Description
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During the seeg case, surgeon instructed the company field service engineer (fse), to drive to the planned trajectory.After the robot reached the entry point, surgeon stopped the robot and sent it back to the home position in order to change the arm¿s angle of entry.After the angle of entry was changed, surgeon instructed the fse to drive back to the trajectory.As the arm approached entry, the arm collided with the telescopic arm under the drape.The software detected a collision, and the fse instructed surgeon to clear the arm.Delay less than 2 minutes.The arm was sent to home and surgeon proceeded to drive to the trajectory with the original angle.The electrode was placed successfully and the case proceeded as normal with all 10 planned electrode placed.
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Manufacturer Narrative
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A full analysis of the data logs has been performed.The complaint description described a collision between the arm of the robot and the support arm that occurred during the guidance to a trajectory.However, the analysis did not allow to confirm the collision due to the absence of error messages in the logs provided.The complaint is non-verifiable.
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Event Description
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During the seeg case, surgeon instructed the company field service engineer (fse), to drive to the planned trajectory.After the robot reached the entry point, surgeon stopped the robot and sent it back to the home position in order to change the arm¿s angle of entry.After the angle of entry was changed, surgeon instructed the fse to drive back to the trajectory.As the arm approached entry, the arm collided with the telescopic arm under the drape.The software detected a collision, and the fse instructed surgeon to clear the arm.Delay less than 2 minutes.The arm was sent to home and surgeon proceeded to drive to the trajectory with the original angle.The electrode was placed successfully and the case proceeded as normal with all 10 planned electrode placed.
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Search Alerts/Recalls
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