There has been a previous report received where this malfunction has caused file separation.Since separation of a file could necessitate medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, this malfunction would be likely to cause/contribute to a serious injury should it recur.As such, this event meets the criteria for reportability per 21 cfr part 803.(b)(4):micromotor (b)(4) (bearing damage) defective, replaced with (b)(4).Battery (voltage collapses under load) defective, replaced.Contra-angle handpiece, power supply unit and foot control were not included.Function test without errors.
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