RELIANCE VISION SINGLE-CHAMBER WASHER/DISINFECTOR

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE UNIT. THE TECHNICIAN FOUND THAT THE INTERNAL HOSE THAT SUPPLIES LUBRICANT WAS LEAKING ONTO THE HEATING ELEMENTS AND INSULATION LOCATED UNDERNEATH RESULTING IN THE REPORTED EVENT. THE TECHNICIAN MADE THE NECESSARY REPAIRS, TESTED THE UNIT, CONFIRMED IT TO BE OPERATING ACCORDING TO SPECIFICATIONS, AND RETURNED IT TO SERVICE. THE UNIT IS NOT UNDER STERIS SERVICE AGREEMENT FOR MAINTENANCE ACTIVITIES. THE USER FACILITY IS RESPONSIBLE FOR ALL MAINTENANCE ACTIVITIES. A 3-YEAR COMPLAINT REVIEW INDICATES THIS TO BE AN ISOLATED EVENT. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED THAT THEIR RELIANCE VISION SINGLE-CHAMBER WASHER/DISINFECTOR WAS EMITTING SMOKE. NO REPORT OF INJURY.

Additional Manufacturer Narrative

OUR INVESTIGATION IS CURRENTLY IN PROCESS. A FOLLOW-UP MDR WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE.