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

Model Number	5052
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that as an employee was unloading their amsco 5052 washer/disinfector, the door of the unit closed on the employee's hand resulting in an injury.Medical treatment was sought and administered, and the employee returned to work.
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the amsco 5052 washer/disinfector and found it to be operating according to specification.The technician stated that the door was functioning normally and closing at the correct speed.The technician also found that there were no issues with the function of the door safety switches.No repairs were required, and the unit was returned to service.The reported event is attributed to user error as the employee should have ensured that their hand was away from the unit's threshold when the door of the unit was closing.A steris account manager conducted in-service training with user facility personnel on the proper use and operation of the amsco 5052 washer/disinfector, specifically on safe operating protocols.No additional issues have been reported.

• Brand Name: AMSCO 5052 WASHER/DISINFECTOR
• Common Device Name: WASHER/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: 16638068
• Report Number: 9680353-2023-00008
• Device Sequence Number: 12121319
• Product Code: MEC
• UDI-Device Identifier: 00724995192976
• UDI-Public: 00724995192976
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 03/29/2023

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: 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: 03/02/2023
• Initial Report FDA Received Date: 03/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2019
• 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