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 06/30/2020 |
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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Around 8:47am edt, while driving to the first trajectory, the robotic arm collided with the mayfield adaptor on the support arm that was not being used.An or staff member was driving the robot at the time, and both he and the surgeon did not notice the mayfield adaptor possibly being in the way under the drape.By the time the zimmer biomet field service engineer (fse) saw the arm getting too close, it was too late, and the collision had happened.The patient was not directly connected to the robot, so the collision did not harm the patient in any way.The patient's head was supported on the bed with a head coil.After the collision, the robot needed to be restarted.After restarting, the arm was moved away from the mayfield adaptor, and then the angle of the arm was changed for guidance to the first trajectory again.There were no other issues after the angle of the arm was changed.Patient was under anesthesia and no incisions were made.The total delay was less than 5 minutes.
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Manufacturer Narrative
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A full analysis of the data logs has been performed and concluded that the collision between the robot arm and the mayfield adaptor was detected through the force sensor, which resulted in the forced shutdown of the device.A shutdown is a normal behavior of the device after a collision.The user restarted the device and changed the angle of the arm to guide it back to the first trajectory.The surgery was resumed properly after the angle of the arm was changed.
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Event Description
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Around 8:47am edt, while driving to the first trajectory, the robotic arm collided with the mayfield adaptor on the support arm that was not being used.An or staff member was driving the robot at the time, and both he and the surgeon did not notice the mayfield adaptor possibly being in the way under the drape.By the time the zimmer biomet field service engineer (fse) saw the arm getting too close, it was too late, and the collision had happened.The patient was not directly connected to the robot, so the collision did not harm the patient in any way.The patient's head was supported on the bed with a head coil.After the collision, the robot needed to be restarted.After restarting, the arm was moved away from the mayfield adaptor, and then the angle of the arm was changed for guidance to the first trajectory again.There were no other issues after the angle of the arm was changed.Patient was under anesthesia and no incisions were made.The total delay was less than 5 minutes.
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Search Alerts/Recalls
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