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.The file separation event will be reported via asr, as appropriate.Evaluation found the battery was misused.The battery had 21 working hours and went through 139 charging cycles.With the amount of working hours, there should only have been 11 charging cycles.
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