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

Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	08/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that following a completed cycle, an employee obtained a cut to their finger while retrieving an item from their amsco 7053hp washer/disinfector.The employee self-treated and continued working.
Additional Manufacturer Narrative
Through follow-up with user facility personnel, a steris account manager learned that an employee was removing flat pans sticking beside the washer's rack and the employee's hand became stuck between the rack and the door gasket.The employee proceeded to remove her hand subsequently causing her finger to obtain a cut from the interior metal edge.A steris service technician inspected the amsco 7053hp washer/disinfector and found no issues with the function or operation.A steris service technician inspected the amsco 7053hp washer/disinfector and found no issues with the function or operation.The technician returned the unit to service.The steris account manager stated that user facility personnel have a habit of placing flat pans beside the amsco 7053hp washer/disinfector's rack during the loading process which may cause difficulty during the unloading process.The operator manual states, "general loading guidelines: to properly clean items and to avoid personal injuries, always follow these general loading guidelines: (.) ensure no items stick out or hang out of rack.Always use a rack designed to handle appropriate type of items to be processed." the steris service technician counseled user facility personnel on the proper use and operation of the 7053hp washer/disinfector specifically the importance of following the general loading guidelines.No additional issues have been reported.

• 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: 17746930
• Report Number: 9680353-2023-00033
• Device Sequence Number: 5654082
• Product Code: MEC
• UDI-Device Identifier: 00724995176662
• UDI-Public: 00724995176662
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/14/2023

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
• 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: 08/15/2023
• Initial Report FDA Received Date: 09/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2023
• 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