MAUDE Adverse Event Report: STERIS CANADA ULC AMSCO 7052HP WASHER/DISINFECTOR

Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported via medwatch (b)(4), "our amsco 7052 washer has the robot accessory washer option on it, which uses a special washing rack in it.The 7052 holds the racks down to the water nozzle using twin rollers in the middle of the machine, which hold onto a flange on the washing rack.The robot rack that we have has the flange only on two sides.The problem that we have found is that the rack can be inserted into the washer with flanges in the forward to back configuration instead of the side to side, which doesn't allow the rollers to grab the wash rack.With the rollers disengaged, the wash rack is free to float around in the washer when water flows out of the central post.This raises the potential for damage in the machine.The previous washer rack design we have has the flange all the way around the water attachment post and holds the cart down on the side rails, so the orientation of the rack isn't important." no report of injury.
Additional Manufacturer Narrative
The racks were designed with flanges only on the left and right sides of their water inlet which is located at the center bottom of the rack.This is due to the presence of the filter housing that is attached to the water inlet.For other types of racks that do not require a water filter, flanges can be all around their water inlet.When the rack is inserted into the washer correctly, the brackets on the washer's central water inlet at the bottom of the chamber will grip the rack flanges and secure the rack in place during cycles.The steris account manager contacted the user facility to offer in-service training on the proper rack loading procedures however, the user facility declined.The racks and the 7052hp washer/disinfector were confirmed to be operating properly and the unit was returned to service.Steris evaluated the reported event and determined it does not meet our reporting criteria under 21 cfr part 803.It should be noted that steris is submitting a medical device report (mdr) solely due to the receipt of the user facility medwatch report which is in accordance with our procedures and policies.No additional issues have been reported.

• Brand Name: AMSCO 7052HP 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: 18852324
• Report Number: 9680353-2024-00012
• Device Sequence Number: 12616319
• Product Code: MEC
• UDI-Device Identifier: 00724995176563
• UDI-Public: 00724995176563
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 03/06/2024

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: 02/06/2024
• Initial Report FDA Received Date: 03/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2022
• 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