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

Model Number	7053HP
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	06/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The steris technician learned from facility personnel that the washer's door was jammed on an instrument tray that was sticking out of the rack.The employee attempted to manually clear the obstruction allowing the washer door to close on their arm resulting in the reported event.The steris technician inspected the washer and found it to be operating per specifications.No repairs were required, and the unit was returned to service.The steris operator manual states the following in accordance with personal injury and/or equipment damage hazard and door obstruction: "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" and "if an obstruction is present in the chamber door, do not attempt to remove the object." the root cause to the event is likely attributed to user error.The steris service technician counseled employee 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 bruised their arm while operating an amsco 7053hp washer/disinfector.The employee did not seek professional medical attention and instead self-treated by applying an ice pack to their arm.

• 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 road; mentor, OH 44060
• MDR Report Key: 19732679
• Report Number: 9680353-2024-00023
• Device Sequence Number: 8027645
• Product Code: MEC
• UDI-Device Identifier: 00724995176655
• UDI-Public: 00724995176655
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 07/12/2024

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
• Device Model Number: 7053HP
• Device Catalogue Number: FH19072
• 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: 06/12/2024
• Initial Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2022
• 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