MAUDE Adverse Event Report: CORPORATION STERIS CANADA AMSCO; AMSCO 5052 WASHER/DISINFECTOR

Model Number	5052
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	01/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived on-site to inspect the unit and found that the unit was operating properly.Additionally, the technician confirmed that the unit had alarmed "unload door obstruction" at the time of the event.The operator manual states, "personal injury and/or equipment damage hazard: "if an obstruction is present in the wash chamber door, door safety bar will detect obstruction, and door will automatically stop from closing.Wait until door is fully open before removing obstruction," and "if an obstruction occurs and the chamber door is not fully open, press emergency stop push button prior to removing obstruction." additionally, during the technician's inspection, it was found that the unit had displayed "door safety test required" prior to the reported event.User facility personnel did not perform the door safety test and continued to utilize the unit.The unit is not under steris service agreement for preventive maintenance; the user facility is responsible for all for maintenance activities.A steris account manager completed in-service training on the proper use and operation of the amsco 5052 washer/disinfector, specifically on the importance of following safety operating procedures.The unit was returned to service, and no additional issues have been reported.
Event or Problem Description
The user facility reported that an employee was attempting to clear an obstructed rack from the door of their amsco 5052 washer/disinfector, when the door came down and contacted an employee's hand.The employee received stitches as a result.
Additional Manufacturer Narrative
It has been reported that the employee subject of the event did require surgery on their hand that was injured.No further details have been provided.No additional issues have been reported.

• Brand Name: AMSCO
• Common Device Name: AMSCO 5052 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: 21285343
• Report Number: 9680353-2025-00004
• Device Sequence Number: 12752961
• Product Code: MEC
• UDI-Device Identifier: 00724995192969
• UDI-Public: (01)00724995192969(11)210615
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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
• Report Date (Section B): 01/31/2025

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: FH14043
• 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: 01/06/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/31/2025
• Supplement Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2021
• 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