V-PRO MAX STERILIZER
Received Nov 21, 2025 · Event occurred Oct 22, 2025
Report 3005899764-2025-00091 · MDR key 23619758
Device
Generic name
V-pro Max Sterilizer
Manufacturer
Steris Mexico, S. De R.l. De C.v.Product problems
- Leak/Splash
- Leak/Splash
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE USER FACILITY REPORTED AN OIL LEAK FROM THEIR V-PRO MAX STERILIZER. NO REPORT OF INJURY.
Additional Manufacturer Narrative
A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE V-PRO MAX STERILIZER AND FOUND THE OIL MIST ELIMINATOR FILTER TO THE VACUUM PUMP WAS CLOGGED AND CAUSED OIL TO BUILD UP RESULTING IN THE REPORTED EVENT. THE VACUUM PUMP OIL IS NON-TOXIC AND NOT CONSIDERED HAZARDOUS. TECHNICIAN REPLACED THE OIL MIST ELIMINATOR FILTER TO RESOLVE THE ISSUE, TESTED THE UNIT, CONFIRMED IT TO BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED IT TO SERVICE. THE UNIT WAS INSTALLED IN 2013 AND IS APPROXIMATELY 12 YEARS OLD. NO ADDITIONAL ISSUES HAVE BEEN REPORTED. UDI RELATED DATA CLARIFICATION - THE DEVICE SUBJECT OF THE EVENT WAS MANUFACTURED PRIOR TO UDI COMPLIANCE; THEREFORE, UDI IS NOT APPLICABLE AND WAS NOT INCLUDED IN THE MDR.