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	Use of Device Problem (1670)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that an employee received a burn on their hands after handling an instrument pack that was processed their v-pro max 2 sterilizer.The employee went to the emergency room; however, it is unknown if any medical treatment was received.
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the sterilizer and found the unit to be operating properly.No issues with the function or the operation of the sterilizer were identified, and the sterilizer was returned to service.The employee subject of the reported event was not wearing proper ppe, specifically gloves, while handling the instrument pack.The v-pro max 2 sterilizer operator manual states (pg.35), "ansi/aami st58, 2013, recommends using chemical-resistant gloves when using the sterilization unit." the v-pro max 2 sterilizer operator manual (pg.3) 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 operator manual also states, (pg.9), "failure to thoroughly clean, rinse and dry articles to be sterilized could result in an ineffective sterilization cycle." the technician counseled user facility personnel on the proper use and operation of the v-pro max 2 sterilizer, specifically the importance of wearing proper ppe.No additional issues have been reported.

• 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
• MDR Report Key: 21335312
• Report Number: 3005899764-2025-00012
• Device Sequence Number: 8550375
• Product Code: MLR
• UDI-Device Identifier: 00724995158354
• UDI-Public: (01)00724995158354(11)241030
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/07/2025

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: 01/10/2025
• Initial Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2024
• 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