THE USER FACILITY REPORTED THAT AFTER THE PROCEDURE, IT WAS NOTED THAT THE PATIENT SUSTAINED TWO SECOND-DEGREE BURNS UNDER THE PATIENT'S NAVEL. THE USER FACILITY CLAIMED THAT THE SOURCE OF THE BURNS CAME FROM THE LIGHT CORD USED WITH THE TELESCOPE, BUT THE USER ALSO CLAIMED THAT THE HEAT ORIGINATED FROM THE TELESCOPE AND NOT THE LIGHT CORD. THE USER ALSO REPORTED THAT THE LIGHT CORD WAS TESTED AFTER THE PROCEDURE AND THERE WAS NO PROBLEM FOUND. A REGULAR BURN DRESSING WAS APPLIED TO THE AFFECTED AREA AND THE PATENT WAS RELEASED FROM THE FACILITY THE SAME DAY. THE PATIENT WAS REPORTEDLY DOING FINE.
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Patient 1
THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR INVESTIGATION. THE INVESTIGATION CONFIRMED THAT THE LIGHT GUIDE POST OF THE TELESCOPE BECAME HOT AFTER TESTING THE TELESCOPE FOR AN HOUR WITH THE USE OF AN OLYMPUS TEST LIGHT SOURCE AND AN OLYMPUS TEST LIGHT GUIDE CABLE. THE LIGHT GUIDE POST TEMPERATURE WAS MEASURED TWICE AND THE TEMPERATURE READINGS WERE 44 & 38 DEGREE CELSIUS. IN ADDITION, THE TELESCOPE HAD NICKS AND DENTS, AND THE OUTER TUBE WAS FOUND SHARP DUE TO DEEP SCRATCHES. THIS PHENOMENON WAS ISOLATED TO PHYSICAL DAMAGE AND USER HANDLING. THIS REPORT IS BEING FILED AS AN MDR IN AN ABUNDANCE OF CAUTION.