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 A2637 OBTURATOR BECAUSE IT WAS FROZEN IN POSITION AND WOULD NOT ANGULATE (DEVICE 1). OLYMPUS CONTACTED THE CUSTOMER TO OBTAIN ADD'L INFO REGARDING THE DEVICE. DEVICES LOCKED UP DURING PREPARATION BEFORE A MEDICAL PROCEDURE AND WAS NOT USED IN THE PROCEDURE.