While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury.Therefore, this event meets the criteria for reportability per 21 cfr part 803.The device was not returned for evaluation.A picture of the broken device was received.Evaluation of other devices from this lot have shown that the electricity was shut down / interrupted during the annealing process, due to very heavy electric load shading during that time.A scar has been issued to the original manufacturer to correct this issue.
|