No conclusion can be drawn.No evaluation was performed, as the device was discarded by the customer.This easydrill cranial perforator with unknown lot number was manufactured by micromar.Multiple warnings are included in the easy drill cranial perforator ifu manual including: it is essential to keep the drill perpendicular (90°) at the predetermined point of the skull to be drilled, as an excessive deviation from perpendicularity may cause the product to fail and lead to serious patient injury.Select a drill bit suitable for the bone thickness.This prevents the drill from tearing the bone or brain tissue (similar effect when the bit is not positioned at 90°).If the components of the easy drill cranial perforator become loose during trephination, discontinue use.The drill can cut or tear the dura mater when it unlocks.Check some conditions before performing the procedure, such as the existence of adhering dura mater or other anomalies adjacent to the drilling site.We will continue to track and trend this complaint type.If information is provided in the future, a supplemental report will be issued.
|
It was reported that when surgeon drilled a hole in order to start the craniotomy - tumor resection, the perforator continues to run and as a consequence, the sinus vein was injured which caused bleeding.The surgeon was able to stop the bleeding and the patient condition was fine.It was also reported that there was delay in procedure for approximately 30minutes as a result of this event and the procedure was completed with the same device.
|