V-PRO 1 STERILIZER

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE V-PRO 1 PLUS STERILIZER AND FOUND THAT THE UNIT'S VACUUM PUMP O-RING COMPONENT FAILED, ALLOWING A SMALL OIL LEAK RESULTING IN AN OIL MIST TO EMIT FROM THE UNIT. THE TECHNICIAN MADE THE NECESSARY REPAIRS, TESTED THE UNIT, CONFIRMED IT TO BE OPERATIONAL, AND RETURNED IT TO SERVICE. THE V-PRO 1 STERILIZER SUBJECT OF THE REPORTED EVENT IS APPROXIMATELY 10 YEARS OLD. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED THAT THEIR V-PRO 1 STERILIZER WAS EMITTING A MIST SETTING OFF THE FACILITY'S FIRE ALARM RESULTING IN PROCEDURE CANCELLATIONS. NO REPORT OF INJURY.

Additional Manufacturer Narrative

THE DEVICE SUBJECT OF THE EVENT WAS MANUFACTURED PRIOR TO UDI COMPLIANCE, THEREFORE, UDI IS NOT APPLICABLE AND WAS NOT INCLUDED IN THE MDR.