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.Please note that while this product is not sold in the us, it is considered similar to products that are marketed in the us by dentsply (b)(4).Battery (voltage breaks down under load) defective, replaced.The battery was fully charged.Foot control (b)(4) (loose contact) defective, replaced by (b)(4).Micromotor (b)(4) has no defect.The contra-angle was not included.Function test without error.
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