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 05/13/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Udi# : (b)(4).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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Surgeon called field service engineer for assistance.During seeg procedure, surgeon had placed bolt.Surgeon reported that when moving away from bolt, rosa moved unexpectedly and received warning that collision had occurred.The field service engineer talked surgeon through procedure of restart and attempting to reconnect.When rosa was still unable to connect to arm, and communication error re-occurred, surgeon removed instrument holder and instrument adaptor from rosa arm, while maintaining sterile field.Surgeon was able to re-start and continue surgery.No obvious adverse issues for patient.
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Manufacturer Narrative
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It was reported that a collision was detected by the device and multiple communication failures occurred.Dhr review and review of complaint history did not identify any contributory factors to the event.According to technical investigation the root cause of the collision cannot be determined.The
collision provoked a shutdown of the device, this is a normal behavior.The root cause of the second shutdown is a shared memory error between rosanna_brain and mario_win software.
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Event Description
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Surgeon called field service engineer for assistance.During seeg procedure, surgeon had placed bolt.Surgeon reported that when moving away from bolt, rosa
moved unexpectedly and received warning that collision had occurred.The field service engineer talked surgeon through procedure of restart and attempting to reconnect.When rosa was still unable to connect to arm, and communication error re-occurred, surgeon removed instrument holder and instrument adaptor from
rosa arm, while maintaining sterile field.Surgeon was able to re-start and continue surgery.No obvious adverse issues for patient.
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