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	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2025
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 found that the unit's vacuum pump was leaking oil and required replacement.As a result of the oil leak, the unit likely emitted an oil mist, not smoke.The vacuum pump oil is non-toxic and not considered hazardous.The technician replaced the vacuum pump, tested the unit, confirmed it to be operating according to specification, and returned it to service.No additional issues have been reported.
Event or Problem Description
The user facility reported that their v-pro max 2 sterilizer was emitting "smoke" and leaking oil onto the floor.No report of injury.

• 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: 21536552
• Report Number: 3005899764-2025-00023
• Device Sequence Number: 12546255
• Product Code: MLR
• UDI-Device Identifier: 00724995158354
• UDI-Public: (01)00724995158354(11)210716
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 03/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 02/04/2025
• Initial Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2021
• 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