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 (collapses under load) defective, replaced.Motor (b)(4) (torque too high) defective, replaced with (b)(4).Housing cracked in several places (presumably due to a fall), but has no effect on the function.Function test without errors.
|