V-PRO MAX STERILIZER
Received May 7, 2026 · Event occurred Apr 7, 2026
Report 3005899764-2026-00033 · MDR key 25116253
Device
Generic name
Sterilizer
Manufacturer
Steris Mexico, S. De R.l. De C.v.Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Eye Irritation
Narrative
Description of Event or Problem
THE USER FACILITY REPORTED THAT AN EMPLOYEE EXPERIENCED EYE IRRITATION WHILE OPERATING THEIR V-PRO MAX STERILIZER. IT IS UNKNOWN IF THE EMPLOYEE SOUGHT OR RECEIVED MEDICAL TREATMENT.
Additional Manufacturer Narrative
A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT AND FOUND NO ISSUES WITH THE FUNCTION OR OPERATION; THE TECHNICIAN CONFIRMED THE V-PRO MAX STERILIZER WAS OPERATING TO SPECIFICATIONS. DURING THE TECHNICIANS INSPECTION, HE OBSERVED THAT THE ROOM IN WHICH THE V-PRO MAX STERILIZER IS LOCATED HAD NO VENTILATION. THE TECHNICIAN LEARNED THAT THE USER FACILITY IS IN THE PROCESS OF REPAIRING THEIR AIR CONDITIONING. THE OPERATOR MANUAL STATES, "STERIS RECOMMENDS (IN ACCORDANCE WITH AAMI ST58, 2013) THE ROOM CONTAINING THE STERILIZATION UNIT HAS A VENTILATION SYSTEM CAPABLE OF AN AIR EXCHANGE AT LEAST 10 TIMES PER HOUR." THE V-PRO MAX STERILIZER IS NOT UNDER STERIS SERVICE AGREEMENT FOR PREVENTIVE MAINTENANCE ACTIVITIES. THE USER FACILITY IS RESPONSIBLE FOR ALL MAINTENANCE ACTIVITIES. THE TECHNICIAN RETURNED THE V-PRO MAX STERILIZER TO SERVICE AN 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.