MAUDE Adverse Event Report: STERIS Canada ULC AMSCO; AMSCO 2532 Single-Chamber Washer/Disinfector

Model Number	2532
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that their amsco 2532 single-chamber washer/disinfector caught fire.The fire was extinguished by the fire department and the smoke was contained within the sterilizer.No report of injury.
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the amsco 2532 single-chamber washer disinfector and found that the over-temperature switch had tripped as designed.Further investigation revealed that the user facility was utilizing a non-steris sump filter that did not fit properly within the filter groove at the bottom of the chamber.Due to the improper fit, the filter was positioned at an angle, causing its seal to come into contact with the heating elements, which resulted in the fire event.The technician replaced the sump filter, over-temperature switch and other necessary components.The technician ran a test cycle, confirmed the unit to be operating to specification, and returned it to service.The technician counseled user facility personnel on the importance of using only steris approved replacement filters.The amsco 2532 installation instructions state, "warning - personal injury hazard and/or equipment damage hazard: ¿repairs and adjustments performed by unqualified personnel or installation of unauthorized parts could cause personal injury, result in improper equipment performance, void the warranty or result in costly damage.¿ no additional issues have been reported.

• Brand Name: AMSCO
• Common Device Name: AMSCO 2532 Single-Chamber Washer/Disinfector
• Manufacturer (Section D): STERIS Canada ULC; 490 boulevard armand-paris; quebec G1C 8 A3; CA G1C 8A3
• Manufacturer (Section G): STERIS Canada ULC; 490 boulevard armand-paris; quebec G1C 8 A3; CA G1C 8A3
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; +1(440)259-7401
• MDR Report Key: 50571263
• Report Number: 9680353-2026-00036
• Device Sequence Number: 9891683
• Product Code: MEC
• UDI-Device Identifier: 00724995192761
• UDI-Public: (01)00724995192761(11)170926
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2026

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: 2532
• Device Catalogue Number: FH120101
• 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: 08/03/2026
• Initial Report FDA Received Date: 09/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2017
• 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