Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show the lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under instructions for use, it states, "carefully read the following instructions prior to surgical use.Top jaw must remain fully closed to ensure proper suture passing.Failure to ensure jaw remains fully closed may result in device malfunction.".
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