Model Number ROSA 2.5.8 |
Device Problem
Misconnection (1399)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/13/2017 |
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 will be performed, a follow-up medwatch report will be submitted.
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Event Description
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During an applicative test the arm drifted without anybody touching it.The customer replugged the force sensor cable.Afterwards he did several tests without any drifting.The issue was probably due to a lost contact in the force sensor controller, because the cables were exchanged on (b)(6) 2017.
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Manufacturer Narrative
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The force sensor controller from device (b)(4) was returned to the manufacturer and has been inspected for investigation purpose.It was identified through functional testing on a similar rosa surgical device that this component was defective, and that this is the root cause for the drift reported in this complaint.Based on the available information, it was not possible to determine why the force sensor controller is defective.A new force sensor controller was installed on device (b)(4).
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Event Description
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During an applicative test the arm drifted without anybody touching it.The medtech representative re-plugged the force sensor cable afterwards he did several tests without any drifting.The issue was probably due to a lost contact in the force sensor controller, because the cables were exchanged on 21-apr-2017.
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Search Alerts/Recalls
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