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	Use of Device Problem (1670)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	07/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that an employee obtained a burn after handing instruments that were processed in their v-pro max sterilizer.The employee sought medical treatment; the user facility did not disclose if medical treatment was administered.
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the unit and found the unit to be operating properly.The unit was tested, confirmed to be operating according to specification, and returned to service.No repairs were made.While onsite, steris was informed that the employee was not wearing proper ppe, specifically gloves, while operating the sterilizer.The v-pro max sterilizer operator manual 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."the v-pro max operator manual, (a-1) further states, "dry all items thoroughly.Ensure all moisture is removed from all internal parts (including lumens).If not, residual hydrogen peroxide may remain at cycle completion and/or a cycle abort occurs.Only dry items are to be placed in sterilization unit." while onsite the technician counseled user facility personnel on the importance of wearing proper ppe, specifically gloves, while operating their v-pro max sterilizer and properly drying instruments prior to processing.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: 22919841
• Report Number: 3005899764-2025-00071
• Device Sequence Number: 16040665
• Product Code: MLR
• UDI-Device Identifier: 00724995206987
• UDI-Public: (01)00724995206987(11)190927
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K190103
• 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): 08/28/2025

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: 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: 07/30/2025
• Initial Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2019
• 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