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

Model Number	V-PRO MAX
Medical Device Problem Codes	Fire (1245); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of the event is currently in progress.A follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that their v-pro max sterilizer caught fire.No report of injury.
Additional Manufacturer Narrative
The dealer was dispatched to the facility and arrived onsite to inspect the sterilizer.During the inspection, charred components and wiring were observed within the unit.The dealer provided steris with photos of the unit and internal components.Based on the photos, steris found that the source of the fire is likely attributed to a hydrogen peroxide leak from the loosened tee-fitting located below the unit's reservoir.The hydrogen peroxide leaked onto the components below which caused the reported event to occur.The cause of the loose fitting could not be determined.The sterilizer is not under steris service agreement; the user facility is responsible for all maintenance activities.The user facility did not disclose details regarding the maintenance activities performed on the unit, specifically properly replacing the tee and tightening the fittings.The v-pro max sterilizer is designed with flame-resistant materials and is certified by intertek to ul 61010-1:2012 3rd ed./csa c22.2#61010-1-12:2012, 3rd ed.Safety requirements for electrical equipment for measurement, control and laboratory use, part 1, and ul 61010-2-040:2021, 3rd ed/csa c22.2#61010-2-040:2021 3rd ed., safety requirements, part 2-040 - particular requirements for sterilizers and washer-disinfectors used to treat medical materials.The user facility has requested a quote for another sterilizer to purchase.No additional issues have been reported.
Event or Problem Description
The dealer reported that one of their customer's v-pro max sterilizers caught fire.The damage sustained was contained within the sterilizer.No report of injury.
Additional Manufacturer Narrative
The unit was returned to steris r&d for evaluation.The evaluation found evidence of a leak and a damaged tee-fitting.However, steris r&d was unable to determine whether the leak and tee-fitting damage occurred prior to the reported fire or as a result of it.Due to the damage sustained, steris r&d was unable to determine the cause of the reported event.A replacement unit was installed at the user facility.No additional issues have been reported.

• Brand Name: AMSCO V-PRO
• Common Device Name: V-PRO MAX 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: 23557026
• Report Number: 3005899764-2025-00089
• Device Sequence Number: 9646223
• Product Code: MLR
• UDI-Device Identifier: 00724995206987
• UDI-Public: (01)00724995206987(11)191211
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K190103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/14/2025

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: V-PRO MAX
• Device Catalogue Number: VP30002101
• 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: 10/17/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 12/12/2025; 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2019
• 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