INNOWAVE

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN WAS IMMEDIATELY DISPATCHED TO THE USER FACILITY TO INSPECT THE ULTRASONIC CLEANER. THE TECHNICIAN FOUND THAT ONE OF THE ULTRASONIC TRANSDUCERS HAD SEPARATED INTO TWO PIECES AND THE BOLT THAT HOLDS THE TRANSDUCER TOGETHER HAD BROKEN OFF. THE TRANSDUCERS ARE ELECTROMECHANICAL COMPONENTS THAT GENERATE ULTRASONIC VIBRATIONS DURING WASH CYCLES. THE SEPARATION OF THE TRANSDUCER IS LIKELY TO HAVE DISRUPTED THE ELECTRICAL CONNECTION, WHICH COULD HAVE RESULTED IN OVERHEATING OF THE TRANSDUCER'S WIRING AND LIKELY CAUSED THE REPORTED SMOKE. THE INNOWAVE ECO ULTRASONIC CLEANER IS DESIGNED WITH HEAT-RESISTANT MATERIALS AND CERTIFIED TO IEC 61010-1:2010+AMD1:2016 UL 61010-1, UL 61010-1, 3RD EDITION 2015, CAN/CSA-C22.2 NO. 61010-1-12, 3RD EDITION 2015 SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE PART 1: GENERAL REQUIREMENTS AND IEC 61010-2-040:2015 SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE PART 2-040: PARTICULAR REQUIREMENTS FOR STERILIZERS AND WASHER-DISINFECTORS USED TO TREAT MEDICAL MATERIALS. IN THE CASE OF DAMAGE TO THE TRANSDUCERS, THE ULTRASONIC CLEANER IS DESIGNED TO ABORT THE WASH CYCLE, EMIT AN AUDIBLE ALARM, AND DISPLAY ERROR CODE "ERROR 39 SONIC GENERATOR OVER CURRENT". THE INNOWAVE ECO ULTRASONIC CLEANER OPERATOR MANUAL PROVIDES USERS WITH THE NECESSARY INSTRUCTIONS TO ADDRESS THE ALARM. IT SHOULD BE NOTED THAT AN OPERATOR MANUAL IS SHIPPED WITH EVERY ULTRASONIC CLEANER. THE OPERATOR MANUAL STATES THE FOLLOWING TO ADDRESS THIS ALARM, "SWITCH THE EQUIPMENT OFF, THEN ON AGAIN. IF PROBLEM PERSISTS, CONTACT SUPPLIER TO ARRANGE A QUALIFIED TECHNICIAN INSPECTION." DUE TO THE DAMAGE TO THE ULTRASONIC CLEANER, STERIS WAS UNABLE TO OBTAIN THE CYCLE LOGS TO DETERMINE THE ALARM STATE AT THE TIME OF THE EVENT. THEREFORE, IT COULD NOT BE CONFIRMED WHETHER THE ULTRASONIC CLEANER ALARMED PRIOR TO THE REPORTED EVENT. ADDITIONALLY, THE OPERATOR MANUAL STATES, "CAUTION - EQUIPMENT DAMAGE DO NOT DROP ITEMS INTO THE WASH TANK AS THIS COULD DAMAGE THE ULTRASONIC TRANSDUCERS." THE ULTRASONIC CLEANER WAS MANUFACTURED IN 2019 MAKING IT APPROXIMATELY SIX YEARS OLD AT THE TIME OF THE EVENT AND IS UNDER STERIS SERVICE AGREEMENT FOR MAINTENANCE ACTIVITIES. THE LAST MAINTENANCE VISIT PRIOR TO THE REPORTED EVENT WAS COMPLETED ON MAY 30, 2025; NO ISSUES WITH THE TRANSDUCER WIRING WERE IDENTIFIED AT THAT TIME. THE ULTRASONIC CLEANER SUBJECT OF THIS EVENT WAS REMOVED FROM SERVICE AND THE USER FACILITY WAS PROVIDED WITH A REPLACEMENT UNIT. A TWO-YEAR COMPLAINT REVIEW CONFIRMED THIS TO BE AN ISOLATED EVENT. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Additional Manufacturer Narrative

INVESTIGATION OF THE EVENT IS CURRENTLY IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

THE USER FACILITY REPORTED THAT THEIR INNOWAVE ECO ULTRASONIC CLEANER WAS SMOKING. NO REPORT OF INJURY.