MAUDE Adverse Event Report: CORPORATION STERIS CANADA AMSCO; AMSCO 7053L SINGLE-CHAMBER WASHER/DISINFECTOR

Model Number	7053L
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the amsco 7053l single-chamber washer/disinfector and found that one of the unit's electrical contactors was damaged.The purpose of the contactor is to provide power to the unit's heating elements.The contactor is activated several times throughout the duration of the cycle.As the contactor was observed to be stuck in the closed position, the drying components in the unit likely began to overheat subsequently causing the reported event.The technician replaced the contactor and the over-temperature switch, ran a test cycle, confirmed the unit to be operating according to specifications, and returned it to service.A 3-year complaint review indicates this to be an isolated event.No additional issues have been reported.
Event or Problem Description
The user facility reported that their amsco 7053l single-chamber washer-disinfector emitted smoke during a cycle.The power to the unit was shut off.No report of injury; however, the facility reported that procedures had to be postponed due to the spread of smoke within the surgical department.

• Brand Name: AMSCO
• Common Device Name: AMSCO 7053L SINGLE-CHAMBER WASHER/DISINFECTOR
• Manufacturer (Section D): CORPORATION STERIS CANADA; 490 boulevard armand-paris; quebec, G1C 8 A3; CA G1C 8A3
• Manufacturer (Section G): CORPORATION STERIS CANADA; 490 boulevard armand-paris; quebec, G1C 8 A3; CA G1C 8A3
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 21857975
• Report Number: 9680353-2025-00019
• Device Sequence Number: 4684558
• Product Code: MEC
• UDI-Device Identifier: 00724995152079
• UDI-Public: (01)00724995152079(11)180117
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 04/17/2025

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: 7053L
• Device Catalogue Number: FH41
• 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: 03/18/2025
• Initial Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2018
• 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