Model Number ROSA 2.5.8 |
Device Problem
Difficult To Position (1467)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/17/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The device articulated arm has been replaced by a new one.The removed articulated arm has not been evaluated yet for investigation purpose.Once the evaluation will be performed, a follow-up medtwatch will be submitted.
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Event Description
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Surgeon reported that the articulated arm of the device was more difficult to set up than during previous uses.
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Manufacturer Narrative
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No further investigation was needed for this incident in which the device (b)(4) was involved.Zfa 2017-268 has been raised in our quality management system to replace the articulated arms.
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Search Alerts/Recalls
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