MAUDE Adverse Event Report: STERIS CANADA ULC AMSCO 7053HP WASHER/DISINFECTOR

Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	12/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the washer and found it to be operating per specifications and no repairs were required.While onsite, the technician learned that a user scraped their hand while attempting to manually clear obstruction from the washer door.The root cause of the event was determined as user error as the employee should not have manually cleared the obstruction from the washer door.The amsco 7053hp washer operator manual states (1-2) "safety precautions if an obstruction is present in the wash chamber door, the door safety bar will detect an obstruction and the door will automatically stop from closing.Wait until door is fully open before removing obstruction." the steris service technician counseled user facility personnel on proper loading techniques and safety operation protocols.No additional issues have been reported.
Event or Problem Description
The user facility reported that an employee scraped their hand on washer door after pushing a jammed rack into a amsco 7053hp washer.The user facility did not disclose if any medical treatment was sought or administered to facility personnel.

• Brand Name: AMSCO 7053HP 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: 18536738
• Report Number: 9680353-2024-00005
• Device Sequence Number: 7587555
• Product Code: MEC
• UDI-Device Identifier: 00724995176662
• UDI-Public: 00724995176662
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 01/18/2024

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
• 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: 12/20/2023
• Initial Report FDA Received Date: 01/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2022
• 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