MDR event

Additional Manufacturer Narrative

SUBJECT INSTRUMENT WAS EVALUATED BY MFR AND BURR SHAFT WAS FOUND TO BE BENT (.03619" OUT OF SPEC) AND SIGNIFICANT SCORING AND RAGGEDNESS OF THE DISTAL HEAT SHRINK WAS NOTED. THE OUTER TUBE WAS ALSO BENT (.05068"). THIS IS EVIDENE OF POSSIBLE EXCESSIVE SIDE LOAD PRESSURE CAUSING INNER TUBE TO COME IN CONTACT WITH THE OUTER. THIS FRICTION CAN PRODUCE HEAT. REPORT ALSO STATED THAT THERE MAY HAVE BEEN AN INTERRUPTION OF SALINE FLOW THAT COOLS BURR DURING OPERATION WHICH MAY HAVE CONTRIBUTED TO BURR OVERHEATING. SAMPLES WERE TAKEN OUT OF THE SAME LOT# BOX SUBJECT BURR CAME FROM; THEY WERE FOUND TO BE WITHIN SPECIFICATIONS.