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

Model Number	5052
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	06/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that an employee obtained a cut on their finger while operating their amsco 5052 washer.Medical treatment was sought and administered.
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the amsco 5052 washer/disinfector and found it to be operating properly.No repairs were required, and the unit was returned to service.The amsco 5052 washer/ disinfector operator manual states (1-1), "warning - personal injury hazard: risk of pinch point between door and threshold when the door opens.Keep fingers away from threshold." the steris account manager offered in-service training on the proper use and operation of the amsco 5052 washer/disinfector; however, the customer declined the in-service training.No additional issues have been reported.

• Brand Name: AMSCO 5052 WASHER/DISINFECTOR
• Common Device Name: 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 rd; mentor, OH 44060 ; 4403927453
• MDR Report Key: 17343546
• Report Number: 9680353-2023-00027
• Device Sequence Number: 6903572
• Product Code: MEC
• UDI-Device Identifier: 00724995152062
• UDI-Public: 00724995152062
• 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): 07/18/2023

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: FH14
• 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: 06/19/2023
• Initial Report FDA Received Date: 07/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2019
• 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