There has been a previous report received where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21cfr part 803.Visually inspected and verified insert has a tip fracture.Fractured insert cannot be tested for overheating.Multiple unsuccessful attempts were made to obtain the patient outcome.
|