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

Model Number	MAX 2
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the units and found the unit to be operating according to specification.No repairs were made, and the unit was returned to service.The employee subject of the reported event was not wearing the proper ppe, specifically gloves, while handling the packs.The v-pro max 2 sterilizer operator manual (1-2) 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." additionally, the v-pro max 2 sterilizer operator manual states (a-1), "a.Dry all items thoroughly.B.Ensure all moisture is removed from all internal parts (including lumens).If not, residual hydrogen peroxide may remain at cycle completion." while onsite the technician counseled facility personnel on the proper use and operation of their v-pro max 2, specifically on wearing the proper ppe and properly drying instruments before processing.No additional issues have been reported.
Event or Problem Description
The user facility reported that one of their employees received a burn after coming in contact with a wet tray that was processed in the v-pro max 2 sterilizer.The employee went to the er, but it is unknown if medical treatment was administered.

• 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: 24337685
• Report Number: 3005899764-2026-00012
• Device Sequence Number: 4812374
• Product Code: MLR
• UDI-Device Identifier: 00724995158354
• UDI-Public: (01)00724995158354(11)190807
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/13/2026

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: 01/14/2026
• Initial Report FDA Received Date: 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2019
• 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