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.Foot control 51213 (loose contact) defective, replaced by 184488.Battery (voltage breaks down under load) defective, replaced.Micromotor (b)(4), and contra-angle 18690 are not defective.Function test without errors.
|