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

WHILE SETTING UP FOR THE PROCEDURE, THE URODYNAMIC TECHNICIAN PUSHED ON THE BACK PORTION OF THE OBTURATOR TO STRAIGHTEN IT OUT, BUT THE OBTURATOR COULD NOT BE STRAIGHTENED SINCE IT HAD LOCKED IN THE BENT POSITION. ALTHOUGH THE TECHNICAIN SOAKED THE DEVICE IN NUTRA-PH INSTRUMENT MILK BATH, THE OBTURATOR COULD NOT BE RELEASED.