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

Model Number	MAX
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that their v-pro max sterilizer caught fire.No report of injury.
Additional Manufacturer Narrative
Investigation of the reported event is currently in progress.A follow-up report will be submitted when additional information becomes available.
Additional Manufacturer Narrative
Through follow-up with user facility personnel, it was confirmed that the v-pro max sterilizer is not available for evaluation.Following the reported event, the v-pro max sterilizer was removed from the building and placed outside by the fire department.When the steris service technician arrived onsite to evaluate the v-pro max sterilizer, it was unable to be located.The facility believes the unit was inadvertently discarded.Without the evaluation of the v-pro max sterilizer, the cause of the reported event could not be determined.If the unit is located in the future, a follow-up report will be submitted.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
• MDR Report Key: 22089072
• Report Number: 3005899764-2025-00044
• Device Sequence Number: 17874193
• Product Code: MLR
• UDI-Device Identifier: 00724995151997
• UDI-Public: (01)00724995151997(11)170217
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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): 05/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 04/29/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 07/17/2025; 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/17/2017
• 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