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.After inspection found battery - voltage collapses under load - defective, replaced.Micromotor (b)(4), contra-angle handpiece (b)(4) (2006) and foot control (b)(4) are not defective.Function test without errors.
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