MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. V-PRO; V-PRO MAX 2 STERILIZER

Model Number	V-PRO
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	02/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that an employee received a burn while removing an empty sterilant cup from their v-pro max 2 sterilizer.The employee sought medical attention however, it is unknown what, if any treatment that may have been received.
Additional Manufacturer Narrative
Following the reported event a steris service technician arrived onsite to inspect the v-pro max 2 sterilizer.The technician inspected the unit and found it to be operating to specifications.No issues were noted with the function or operation of the device and the sterilant cup interface door was operating to specifications.The technician was informed that the employee subject of the reported event was wearing gloves however, user facility personnel declined to provide additional details regarding the event and if the employee was wearing other personal protective equipment (ppe).As no issues were noted with the function or operation of the unit and the user facility declined to provided additional event details, a root cause cannot be determined.The technician returned the v-pro max 2 sterilizer to service and 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: 21712984
• Report Number: 3005899764-2025-00028
• Device Sequence Number: 4514916
• Product Code: MLR
• UDI-Device Identifier: 00724995152673
• UDI-Public: (01)00724995152673(11)240216
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 03/27/2025

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
• Device Catalogue Number: MAX 2
• 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: 02/25/2025
• Initial Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2024
• 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