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

Model Number	5052
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	07/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite following the event to inspect the amsco 5052 single-chamber washer/disinfector and was unable to duplicate the reported event.Upon inspection, the technician found the doors and obstruction safety bars to be functioning properly without issue.The reported event is attributed to user error as the employee should not have tried to manually remove the obstruction from the door.The amsco 5052 operator manual states, "if an obstruction is present at the bottom of the wash chamber door, do not attempt to remove the object.A door safety sensor on the door button detects the obstruction.Door automatically stops from closing and opens completely." the technician counseled the user facility on the importance of following proper procedures for removing obstructions from the washer.No additional issues have been reported.
Event or Problem Description
The user facility reported that their amsco 5052 single-chamber washer/disinfector alarmed and that the door was obstructed.As an employee went to remove the obstruction, the door lowered and contacted their hand resulting in an injury.Medical treatment was sought and administered.

• 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: 22842753
• Report Number: 9680353-2025-00034
• Device Sequence Number: 4927011
• Product Code: MEC
• UDI-Device Identifier: 00724995192952
• UDI-Public: (01)00724995192952(11)171010
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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): 08/19/2025

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: FH14042
• 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: 07/21/2025
• Initial Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2017
• 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