inforMED
MalfunctionMLR

V-PRO

Received Jul 2, 2025 · Event occurred Jun 9, 2025

Report 3005899764-2025-00054 · MDR key 22386016

Device

Generic name

V-pro Max Sterilizer

Model number

MAX 2

Catalog number

VP50002101

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 THAT THEIR V-PRO MAX 2 STERILIZER WAS LEAKING OIL ONTO THE FLOOR. NO REPORT OF INJURY.

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE STERILIZER AND FOUND THAT THE SOURCE OF THE LEAK WAS THE VACUUM PUMP. THE TECHNICIAN HAD TO ORDER THE VACUUM PUMP AS IT WAS ON BACK ORDER. THIS RESULTED IN PROCEDURE POSTPONEMENTS AS THIS IS THE FACILITY'S ONLY STERILIZER. ONCE THE TECHNICIAN RECEIVED THE COMPONENT, THE REPAIR WAS COMPLETED. THE STERILIZER WAS TESTED, FOUND TO BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.