OLYMPUS

Description of Event or Problem

THE CUSTOMER RETURNED 2 OBTURATORS TO CO'S REPAIR FACILITY, BECAUSE THE DEVICES LOCKED IN AN ANGULATED POSITION.

Additional Manufacturer Narrative

UPON EVAL, THE MFR FOUND THAT THE EPOXY CEMENT USED TO SECURE AN INTERNAL SCREW IN THE DEFLECTING TIP OF THE OBTURATOR HAD DETERIORATED OVER TIME. THIS ALLOWED THE SCREW TO SHIFT, AND AS A RESULT, THE OBTURATOR LOCKED IN A DEFLECTED POSITION. TO COUNTER THIS PHENOMENON, THE MFR HAS VALIDATED A CHANGE TO A LASER WELDING PROCESS.