OLYMPUS OPTICAL OBTURATOR

Additional Manufacturer Narrative

OLYMPUS FOLLOWED UP WITH THE USER FACILITY IN AN ATTEMPT TO OBTAIN MORE DETAILED INFORMATION REGARDING THE REPORT, BUT WITH NO SUCCESS. THE DEVICE REFERENCED IN THIS REPORT HAS NOT YET BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE EXACT CAUSE OF THE USER'S REPORT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME DUE TO THE ABSENCE OF THE DEVICE TO INVESTIGATE. IF THE DEVICE IS RECEIVED LATER AND ADDITIONAL AND SIGNIFICANT INFORMATION BECOMES AVAILABLE AT A LATER TIME, THIS REPORT WILL BE UPDATED.

Description of Event or Problem

OLYMPUS WAS INFORMED THAT DURING A BLADDER PROCEDURE THE WHITE CERAMIC DISTAL BEAK OF THE SUBJECT DEVICE BROKE OFF AND FELL INSIDE THE PATIENT. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT, AND X-RAY CONFIRMED THAT NO ADDITIONAL PIECES WERE LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING OTHER EQUIPMENT AND THERE WAS NO PATIENT INJURY REPORTED.