OLYMPUS EVIS EXERA II XENON LIGHT SOURCE

Additional Manufacturer Narrative

THE LIGHT SOURCE AND POWER CORD WERE RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION CONFIRMED THE USER'S REPORT THAT THE SYSTEM WOULD NOT POWER ON. ADDITIONALLY, THE LAMP COVER WAS FOUND TO BE DENTED AT THE KNOB. THERE WAS A BROWN DISCOLORATION AT THE FEMALE CONNECTOR OF THE POWER CORD, INDICATIVE OF A HIGH-TEMPERATURE EVENT. THE REAR PANEL FUSES WERE FOUND TO BE OPEN, AND THE CONVERTER UNIT WAS DAMAGED AND MELTED AT THE FUSE BOX. THE FUSES AND CONVERTER UNIT WERE REPLACED, AND THE LIGHT SOURCE PASSED ALL FUNCTIONAL AND ELECTRICAL TESTS. THE DEVICE WAS REPAIRED AND RETURNED TO THE USER FACILITY. 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 THE LIGHT SOURCE POWERED OFF DURING THE START OF A DIAGNOSTIC COLONOSCOPY AND COULD NOT BE RESTARTED. THE USERS ATTEMPTED TO REPLACE THE POWER CORD WITHOUT SUCCESS. BROWN DISCOLORATION WAS REPORTEDLY OBSERVED ON THE END OF THE POWER CORD THAT HAD BEEN CONNECTED TO THE REAR PANEL OF THE DEVICE. THE USER FACILITY REPORTED THAT THE USERS WITHDREW THE UNIDENTIFIED ENDOSCOPE FROM THE PT, AND TRANSFERRED THE PT TO A DIFFERENT ROOM TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS SAID TO HAVE BEEN COMPLETED WITH A DIFFERENT, BUT SIMILAR VIDEO CART AND THE SAME ENDOSCOPE. THERE WAS NO PT INJURY ASSOCIATED WITH THIS EVENT.