Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that 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 possible adverse effects, it states, "intraoperative and early postoperative complications can include: 1) damage to blood vessels."
this report is number 1 of 2 mdr's filed for the same event (reference 1825034-2015-02209 / 02210).
|