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

Model Number	MAX 2
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	03/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that an employee obtained a burn after handling items that were processed in their v-pro max 2 sterilizers.The employee did not seek medical treatment and continued working.
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the v-pro max 2 sterilizer and found that the pressure calibration values were out of adjustment and recalibrated the temperature probes and pressure transducers.The unit was tested, found to be operating according to specification and was retuned back to service.The technician was informed that the employee was not wearing proper ppe, specifically gloves, while operating the sterilizers as stated in the operator manual.The v-pro max 2 sterilizer operator manual states (6-16), "steris recommends (in accordance with ansi/aami guidelines) wearing chemical-resistant gloves when using the sterilization unit." the operator manual further states (1-2), "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 v-pro max 2 sterilizer operator manual states (a-1), "a.Dry all items thoroughly.B.Ensure all moisture is removed from all internal parts (including lumens).If not, residual hydrogen peroxide may remain at cycle completion." user facility personnel were counseled on the importance of wearing proper ppe, specifically gloves, as well as properly drying instruments prior to processing.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, 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: 21922316
• Report Number: 3005899764-2025-00033
• Device Sequence Number: 8742781
• Product Code: MLR
• UDI-Device Identifier: 00724995158354
• UDI-Public: (01)00724995158354(11)230706
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 04/28/2025

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: 03/28/2025
• Initial Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2023
• 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