USA ELITE SYSTEM ROTATING CF OUTER SHEATH, 25 FR, GOLD

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. OLYMPUS FOLLOWED UP WITH THE USER FACILITY VIA TELEPHONE AND IN WRITING TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT BUT WITH NO RESULT. THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME. HOWEVER, THE INSTRUCTION MANUAL WARNS USERS "DO NOT USE AN INSTRUMENT THAT FAILS TO MEET THE CRITERIA STATED IN THE LABELING OR THAT HAS BEEN DAMAGED. DAMAGE MAY RESULT IN THE LOSS OF THE ENTIRE CERAMIC TIP OR FRAGMENTS OF THE CERAMIC TIP. IF THERE IS EVIDENCE OF CHARRING, BURN SPOTS, CHIPS OR CRACKS IN THE CERAMIC TIP OR SURROUNDING AREA, DO NOT USE. "

Description of Event or Problem

OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE, THE PLASTIC TIP OF THE OUTER SHEATH BROKE OFF INTO THREE PIECES AND FELL INSIDE THE PATIENT. IT WAS REPORTED THAT THE SURGEON RETRIEVED ALL THREE PIECES OF THE PLASTIC TIP FROM THE PATIENT. THE ADJACENT AREAS WERE INSPECTED FOR TRAUMA AND NONE WAS NOTED. IT IS UNKNOWN IF THE INTENDED PROCEDURE WAS COMPLETED.