There has been a previous report received where stalling 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.Battery (voltage breaks down under load) defective, replaced.Foot control 69527 (broken cable) defective, replaced with 188944.The housing is cracked in several places (possibly due to impact) has no effect on the function.Micromotor sm40672 tested, without errors.Function test without errors.Supplied without contra-angle handpiece and power supply.
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