OLYMPUS ULTRASOUND BALLOON CUFF

Additional Manufacturer Narrative

OLYMPUS FOLLOWED UP WITH THE USER FACILITY VIA TELEPHONE AND IN WRITING TO GATHER ADD'L INFO REGARDING THIS REPORT. THE USER FACILITY REPORTED THAT IMMEDIATELY AT THE END OF THE PROCEDURE, THEY DISCOVERED THAT THE BALLOON WAS MISSING. THERE WAS NO PT INJURY REPORTED AND THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THE PT WAS RE-EXAMINED WITH AN UNIDENTIFIED MODEL OF OLYMPUS ENDOSCOPE, BUT THE BALLOON COULD NOT BE LOCATED. THE PT DID NOT REQUIRE ANY FURTHER MEDICAL OR SURGICAL INTERVENTION AND THE USER IS REPORTEDLY UNSURE IF THE BALLOON HAS PASSED. THE DEVICE REFERENCED IN THIS REPORT WAS DISCARDED AND NOT RETURNED TO OLYMPUS FOR EVAL. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

Description of Event or Problem

THE USER FACILITY REPORTED THAT UPON COMPLETION OF A DIAGNOSTIC ENDOSCOPIC ULTRASOUND PROCEDURE, WHEN THE ENDOSCOPE WAS REMOVED FROM THE PT, THE STAFF NOTICED THE BALLOON HAD FAILED AND THE DISTAL TIP OF THE BALLOON WAS MISSING. ATTEMPTS TO LOCATE THE MISSING PART USING A GASTROVIDEOSCOPE WERE NOT SUCCESSFUL. THERE WAS NO PT HARM REPORTED.