While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21cfr part 803.Tested unit upon arrival and handpiece ran to spec.Made 10 cuts in a row non stop and handpiece never heated up.Pulled off cap to inspect and cap bearing came apart.I believe this was only due to disassembling and not from failure.There was no signs of contact on cap and no debris in head or cap.
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