While there is no indication that serious injury resulted in this event, there has been a previous report received where this malfunction 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.
Multiple unsuccessful attempts were made to obtain the device for evaluation.
|