MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. V-PRO; V-PRO MAX 2 STERILIZER

Model Number	MAX 2
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	12/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the v-pro max 2 sterilizer and confirmed that the unit was operating according to specification.No issues were noted with the function and operation.No repairs were required, and the unit was returned to service.The user facility was counseled on the proper use and operation of the sterilizer, specifically on proper safety precautions when moving the sterilizer.The v-pro max 2 sterilizer operator manual states, "warning personal injury and/or equipment damage hazard lifting or moving the sterilization system required more than one person.Note unit weight (refer to installation checklist in operator manual.)" no additional issues have been reported.
Event or Problem Description
The user facility reported that after an instrument fell underneath their v-pro max 2 sterilizer, an employee moved the unit to retrieve the instrument and obtained a cut on their hand.The employee washed their hands, applied bandages, and returned to work.

• Brand Name: V-PRO
• Common Device Name: V-PRO MAX 2 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: 24005701
• Report Number: 3005899764-2026-00001
• Device Sequence Number: 4746656
• Product Code: MLR
• UDI-Device Identifier: 00724995158354
• UDI-Public: (01)00724995158354(11)181228
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 01/08/2026

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: 12/09/2025
• Initial Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/28/2018
• 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