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 21 cfr part 803.Handpiece didn't get hot.Handpiece failed specs due to cap sticking inwards position.Visible black mark on center of cap due to coming intact with rotor on turbine.Cap is clean and has no signs of debris built up around edges of cap.Replaced head drive.Replaced water hoses and water valve.
|