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.
The device was not returned for evaluation.
However, the serial number was provided and a dhr review is planned.
The results will be submitted as they become available.
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