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

Model Number	MAX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	04/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user facility declined to have steris inspect the sterilizer subject of the reported event and elected to perform their own internal evaluation.User facility personnel stated to steris that no issues were noted with the function or operation of the sterilizer during their evaluation.Through follow-up with user facility personnel, it was discovered that the employee subject of the reported event was not wearing the proper ppe, specifically gloves, while handing packs processed in the v-pro max sterilizer.The v-pro max sterilizer operator manual (1-2) 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." additionally, the v-pro max 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." steris has offered in-service training on the proper use and operation of the v-pro max sterilizer and is awaiting a response.No additional issues have been reported.Udi related data clarification - the lot/serial number is unknown; therefore, the applicable production identifiers were not included in the mdr.
Event or Problem Description
The user facility reported that an employee obtained a burn to their hands after handling a tray that was processed in their v-pro max sterilizer.No medical treatment was sought or administered.

• Brand Name: AMSCO 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 ; 4402597401
• MDR Report Key: 25116249
• Report Number: 3005899764-2026-00034
• Device Sequence Number: 9292488
• Product Code: MLR
• UDI-Device Identifier: 00724995151997
• UDI-Public: (01)00724995151997
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 05/07/2026

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
• Device Catalogue Number: VP3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/07/2026
• Supplement Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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