Model Number ROSA BRAIN |
Device Problem
Unintended Collision (1429)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/19/2018 |
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.
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Event Description
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After finishing contactless registration on patient, the robot arm collided with the mayfield head holder during automatic move back to the home position.System then shutdown.Patient was already asleep, no clinical consequences.A field service engineer was present but not driving the rosa.
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Manufacturer Narrative
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It was reported that a collision between the robot arm and the mayfield head holder occurred during a surgery.Dhr review and review of complaint history did not identify any contributory factors to the event.According to technical investigation the collision is confirmed.Review of the ifu and the training concluded that this collision could have been avoided by releasing the pedal as it is explained in the ifu.The root cause of this event is an use error.
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Event Description
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After finishing contactless registration on patient, the robot arm collided with the mayfield head holder during automatic move back to the home position.System then shutdown.Patient was already asleep, no clinical consequences.A field service engineer was present but not driving the rosa.
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Search Alerts/Recalls
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