OLYMPUS

Description of Event or Problem

THE USER FACILITY REPORTED THAT DURING A THERAPEUTIC GASTROINTESTINAL PROCEDURE, THERE WAS NO WATER FEEDING FROM THE TIP OF THE HEAT PROBE WHILE THE PT WAS BLEEDING. THE BLEEDING WAS SAID TO HAVE CONTAINED WITH THE USE OF A DIFFERENT, BUT SIMILAR HEAT PROBE AND HEAT PROBE UNIT. THE PROCEDURE WAS COMPLETED AND THERE WAS NO PT INJURY REPORTED. THE USER FACILITY CLAIMED THAT THEIR BIOMEDICAL ENGINEER DEPT TESTED THE DEVICE AFTER THE PROCEDURE AND WAS ABLE TO DUPLICATE THEIR REPORT.

Additional Manufacturer Narrative

THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR INVESTIGATION. THE INVESTIGATION DID NOT DUPLICATE THE USER'S REPORT OF NO WATER FEEDING AFTER THE DEVICE WAS TESTED FOR SEVERAL HOURS WITH NO PROBLEMS FOUND. THE DEVICE PASSED ALL THE FUNCTIONAL TESTS. THE CAUSE OF THE USER'S EXPERIENCE CANNOT BE CONCLUSIVELY DETERMINED. HOWEVER, THE HEAT PROBE OR WATER PUMP, WHICH WAS NOT RETURNED TO OLYMPUS FOR INVESTIGATION, CANNOT BE RULED OUT AS CONTRIBUTING FACTORS TO THE USER'S EXPERIENCE. THIS REPORT IS BEING FILED AS AN MDR IN AN ABUNDANCE OF CAUTION.