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

Model Number	max 2
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Caustic/Chemical Burns (2549)
Date of Event	08/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that an employee obtained burns and an allergic reaction after handling a wrapped tray that was processed in their v-pro max 2 sterilizer.User facility personnel stated the employee's hands began to swell, and the employee subsequently experienced respiratory irritation.The employee subject of the reported event sought medical treatment at the er.The user facility did not disclose the type of treatment that may have been administered.
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the v-pro max 2 sterilizer and found the unit to be operating properly.No issues were noted with the function or operation of the unit and the sterilizer was returned to service.The technician was informed that the employee was not wearing proper ppe, specifically gloves, while operating the v-pro max 2 sterilizer.The v-pro max 2 sterilizer operator manual (pp.50) states, ¿ansi/aami st58, 2013, recommends using chemical-resistant gloves when using the sterilization unit¿.The v-pro max 2 sterilizer operator manual (pp.2) 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.¿ additionally, user facility personnel should ensure all instruments are properly dry prior to placement in the v-pro max 2 sterilizer.The operator manual states, ¿dry all items thoroughly.Ensure all moisture is removed from all internal parts (including lumens).If not, residual hydrogen peroxide may remain at cycle completion and/or a cycle abort occurs.Only dry items are to be placed in sterilization unit.¿ as a preventive measure, the technician replaced sv3 and tightened the reservoir.The technician counseled user facility personnel on the importance of inspecting the biological indicator prior to use and wearing proper ppe, specifically gloves, while operating the v-pro max 2 sterilizer.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 nuevo leon 67190 ; MX 67190
• Manufacturer (Section G): STERIS MEXICO, S. de R.L. de C.V.; avenida avante 790; parque industrial guadalupe; guadalupe nuevo leon 67190 ; MX 67190
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; +1(440)259-7401
• MDR Report Key: 50836760
• Report Number: 3005899764-2026-00072
• Device Sequence Number: 10270562
• Product Code: MLR
• UDI-Device Identifier: 00724995158354
• UDI-Public: (01)00724995158354(11)241206
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 09/21/2026

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: 08/23/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2024
• 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