MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. V-PRO; STERILIZER

Model Number	MAX 2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of the reported event is in process; a follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that an employee obtained a burn after unloading their v-pro max 2 sterilizer.It is unknown if medical treatment was sought or administered.
Event or Problem Description
The user facility reported that two employees obtained a burn after unloading their v-pro max 2 sterilizer.It is unknown if medical treatment was sought or administered.
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the unit and found that the sv4 valve required replacement.As designed, the sterilizer had alarmed and aborted the cycle.To resolve the issue, the technician replaced the sv4 valve.The unit was tested, confirmed to be operating according to specification, and returned to service.While onsite, the technician was informed that neither of the employees were not wearing proper ppe, specifically gloves, while handling instruments after the aborted cycle.The v-pro max 2 sterilizer operator manual states, "steris recommends (in accordance with ansi/aami guidelines) wearing chemical-resistant gloves when using the sterilization unit." the operator manual further states, "danger - chemical injury hazard: any visible liquids in the chamber or on the load must be treated as concentrated hydrogen peroxide.Observe all hydrogen peroxide handling precautions.When handling hydrogen peroxide, wear appropriate personal protective equipment." the unit is not under steris service agreement for preventive maintenance activities; the user facility is responsible for all maintenance activities.While onsite the technician counseled user facility personnel on the proper use and operation of the v-pro max 2 sterilizer, specifically on wearing appropriate ppe when an aborted cycle occurs.No additional issues have been reported.

• Brand Name: V-PRO
• Common Device Name: STERILIZER
• Manufacturer (Section D): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, 67190 ; MX 67190
• Manufacturer (Section G): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, 67190 ; MX 67190
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4402597401
• MDR Report Key: 23657233
• Report Number: 3005899764-2025-00092
• Device Sequence Number: 15942985
• Product Code: MLR
• UDI-Device Identifier: 00724995158354
• UDI-Public: (01)00724995158354(11)220419
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: MAX 2
• Device Catalogue Number: VP50002101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 12/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown