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

ALTHOUGH THE A2636, 24 FR OBTURATOR, WAS LOADED INTO THE SHEATH PRIOR TO THE PROCEDURE, HOSP PERSONNEL WERE UNABLE TO UNLOAD THE OBTURATOR SINCE THE DISTAL TIP WAS STUCK IN A FLEXED POSITION. ALTHOUGH THE SURGEON WAS FINALLY ABLE TO UNLOAD THE DEVICE WITH THE USE OF GREAT FORCE AND SOME LUBRICANT, THE FLEXIBLE TIP NEVER STRAIGHTENED OUT. PRIOR TO THIS EVENT, THE OBTURATOR WAS USED APPROXIMATELY FIVE TIMES BUT THIS WAS THE ONLY OCCURRENCE OF THE DEVICE LOCKING IN THE FLEXED POSITION.