OLYMPUS ENDOSCOPE REPROCESSOR

Description of Event or Problem

OLYMPUS WAS INFORMED THAT THE SUBJECT DEVICE EMITTED A BURNING ODOR AND DISPLAYED AN E11 ERROR CODE. THERE WAS NO ADVERSE IMPLANT TO PTS OR USERS.

Additional Manufacturer Narrative

OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADD'L INFO REGARDING THIS REPORT. THE USER FACILITY REPORTED THAT THERE WAS NO ARCING, SPARKING AND OPEN FLAME OBSERVED, ONLY A BURNING ODOR. THERE WAS NO ADVERSE IMPACTS TO ANY PTS OR USERS REPORTED. AN OLYMPUS FIELD SERVICE ENGINEER (FSE) VISITED THE USER FACILITY AND FACILITY AND EVALUATED THE REPROCESSOR. DURING THE EVAL, THERMAL DAMAGE WAS NOTED TO THE CPU PRINTED CIRCUIT BOARD (PCB). THE FSE REPLACED THE CPU, HOWEVER THE REPLACEMENT CPU PCB ALSO EMITTED A BURNING ODOR WHEN A REPROCESSING CYCLE WAS INITIATED. THE CPU BOARD AND PUMP UNIT WERE REPLACED, AND THE UNIT OPERATED APPROPRIATELY. THE TWO CPU PCBS AND THE PUMP UNIT WERE RETURNED TO OLYMPUS FOR EVAL. THE EVAL FOUND COMPONENTS ON BOTH OF THE CPU BOARDS WITH EVIDENCE OF THERMAL DAMAGE. THE RESISTANCE OF THE PUMP UNIT WAS MEASURED AT 0.2 OHMS WHICH WAS SIGNIFICANTLY LOWER THAN THE NORMAL RESISTANCE READING INDICATING A SHORT WITHIN THE PUMP CAUSING EXCESSIVE CURRENT FLOW ON THE CPU PCB. THE PUMP UNIT WAS INADVERTENTLY DISCARDED, HOWEVER THE CPU PCBS HAVE BEEN FORWARDED TO THE ORIGINAL EQUIPMENT MFR (OEM) FOR FURTHER EVAL. THIS REPORT IS BEING SUBMITTED AS AN MDR IN AN ABUNDANCE OF CAUTION.