MAUDE Adverse Event Report: CORPORATION STERIS CANADA AMSCO; WASHER/DISINFECTOR

Model Number	5052
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	10/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the door to their amsco 5052 single-chamber washer/disinfector dropped contacting an employee's fingers.The employee obtained a bruise on two fingers; however, the employee did not seek medical treatment and continued working.
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the unit and found that a screw between the plastic guide and door of the unit had fallen out.This caused the door to become stuck at the top and suddenly drop, subsequently causing the reported event.To resolve the issue, the technician reinstalled the screw.The unit was tested, confirmed to be operating according to specification, and returned to service.No additional issues have been reported.

• Brand Name: AMSCO
• Common Device Name: 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 ; 4402597401
• MDR Report Key: 23498897
• Report Number: 9680353-2025-00047
• Device Sequence Number: 13023807
• Product Code: MEC
• UDI-Device Identifier: 00724995192976
• UDI-Public: (01)00724995192976(11)210517
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/07/2025

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: 5052
• Device Catalogue Number: FH14072
• 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: 10/08/2025
• Initial Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2021
• 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