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 Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	07/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Steris has made multiple attempts to obtain additional information regarding the two employees subject of the reported event; however, the user facility has not responded.A steris service technician arrived onsite following the reported event to inspect the v-pro max 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 v-pro max sterilizer operator manual 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." the operator manual further states, "ansi/aami st58, 2013, recommends using chemical-resistant gloves when using the sterilization unit." no additional issues have been reported.
Event or Problem Description
The user facility reported that two employees obtained burns while removing vaprox hc sterilant cups from their v-pro max sterilizer.It is unknown if medical treatment was sought or administered.

• 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: 22740298
• Report Number: 3005899764-2025-00066
• Device Sequence Number: 13087871
• Product Code: MLR
• UDI-Device Identifier: 00724995206987
• UDI-Public: (01)00724995206987(11)200127
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/07/2025

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: 07/08/2025
• Supplement Date Received by Manufacturer: Not provided; 07/11/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 11/06/2025; 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2020
• 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