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

Model Number	V-PRO MAX
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation in process.A follow-up mdr will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that during a cycle, their v-pro max sterilizer caught on fire and the fire department was dispatched.No report of injury.
Additional Manufacturer Narrative
The steris service technician arrived on site to inspect the v-pro max sterilizer and due to the damage sustained, was unable to determine the cause of the reported event.In lieu of repairing the unit, the customer received a new unit.The unit was returned to steris for further investigation.The investigation revealed that the electrical connectors, wire insulation and corrugated tubing were all damaged.While a definitive root cause could not be determined, a potential cause of the event may be attributed to a hydrogen peroxide leak from a loosened plastic fitting located below the reservoir.The hydrogen peroxide may have leaked onto the components below which could have caused the unit's heater circuit to overheat resulting in the reported event.No additional issues have been reported.
Additional Manufacturer Narrative
While a definitive root cause could not be determined, it appears that vaprox hc sterilant leaked from the fitting and dripped onto the heater wires and electrical connectors below causing the heater circuit to overheat resulting in the reported event.The sterilizer was installed in 2017 and was under steris service agreement for maintenance activities at the time of the event.The last preventive maintenance visit prior to the reported event was completed on (b)(6) 2024.At that time, the technician replaced the tee.While the exact cause of the loose fitting could not be determined, it may have been due to the technician not properly tightening the fitting during the previous service visit.As a preventive measure, the technician was counseled on proper preventive maintenance activities, specifically properly replacing the tee and tightening the fittings.A 2-year complaint review indicates this to be an isolated event.The v-pro max sterilizer is designed with flame-resistant materials and is certified by intertek to ul 61010-1:2012 3rd ed./csa c22.2#61010-1-12:2012, 3rd ed.Safety requirements for electrical equipment for measurement, control and laboratory use, part 1, and ul 61010-2-040:2021, 3rd ed/csa c22.2#61010-2-040:2021 3rd ed., safety requirements, part 2-040 - particular requirements for sterilizers and washer-disinfectors used to treat medical materials no additional issues have been reported.

• 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
• MDR Report Key: 19553700
• Report Number: 3005899764-2024-00027
• Device Sequence Number: 11945594
• Product Code: MLR
• UDI-Device Identifier: 00724995206987
• UDI-Public: (01)00724995206987(11)170918(21)032611708
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 06/17/2024

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: 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: 05/21/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 10/24/2024; 12/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2017
• 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