V-PRO

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT AND CONFIRMED THAT THE CYCLE DURING THE REPORTED EVENT HAD ABORTED FOR A "TOO LONG TO EVACUATE" ALARM. THE TECHNICIAN INSPECTED THE V-PRO 60 STERILIZER AND FOUND THAT THE SV4 VALVE WAS DAMAGED. DURING FOLLOW UP WITH USER FACILITY PERSONNEL, THE TECHNICIAN LEARNED THAT THE EMPLOYEE SUBJECT OF THE REPORTED EVENT WAS NOT WEARING GLOVES WHILE HANDLING THE INSTRUMENT PACK. THE OPERATOR MANUAL STATES (PG.51), "STERIS RECOMMENDS (IN ACCORDANCE WITH ANSI/AAMI ST58, 2013) WEARING CHEMICAL-RESISTANT GLOVES WHEN REMOVING ITEMS FROM THE STERILIZATION UNIT AFTER A CYCLE HAS BEEN ABORTED." THE TECHNICIAN COUNSELED USER FACILITY PERSONNEL ON THE IMPORTANCE OF WEARING GLOVES WHEN AN ABORTED CYCLE OCCURS. THE V-PRO 60 STERILIZER WAS REPAIRED, CONFIRMED TO BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED THAT AN EMPLOYEE RECEIVED A BURN TO THEIR FINGERS WHILE HANDLING AN INSTRUMENT PACK AFTER AN ABORTED CYCLE IN THEIR V-PRO 60 STERILIZER. THE EMPLOYEE SOUGHT MEDICAL TREATMENT AT A WALK-IN CLINIC; HOWEVER, IT IS UNKNOWN WHAT TYPE OF TREATMENT WAS RECEIVED.