OLYMPUS

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.

Description of Event or Problem

THE CUSTOMER RETURNED AN OBTURATOR TO CO'S REPAIR FACILITY, BECAUSE THE TIP WOULD NOT ANGULATE. THE OBTURATOR WAS LOCKED IN POSITION. ON MARCH 4, 1998 THE OBTURATOR LOCKED IN POSITION DURING PREPARATION, PRIOR TO THE PROCEDURE TO BE PERFORMED. A SECOND DEVICE WAS USED TO PERFORM THE PROCEDURE AND NO PROBLEMS WERE ENCOUNTERED. THE CUSTOMER WOULD NOT RELEASE ANY INFO REGARDING THE PROCEDURE BEING PERFORMED, SINCE THE FAILED DEVICE WAS NOT USED DURING THE PROCEDURE.