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

Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported via medwatch mw5119138, that preventive maintenance (pm) on their amsco 7053l washer/disinfector was unable to be completed due to pm parts being on backorder.
Additional Manufacturer Narrative
The user facility contacted steris via service request on (b)(6) 2023, to perform preventive maintenance activities for their amsco 7053l washer/disinfector.Steris schedules service activities (repair and preventive maintenance) based on availability of service technicians.Pm activities are prioritized for customers on a steris service contract.The amsco 7053l washer/disinfector at (b)(6) is not under a service contract with steris.The user facility is responsible for service and all preventive maintenance activities for the equipment.Contrary to the reported event the service parts needed to complete the pm activity were not on backorder.Due to the steris service technician's availability, the preventive maintenance activities for the subject amsco 7053l washer/disinfector were scheduled and completed on (b)(6) 2023.In-between the service request activity on (b)(6) 2023, and the preventive maintenance activity on (b)(6) 2023, user facility personnel continued to use the amsco 7053l washer/disinfector as no issues were noted with the function or operation of the device.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.

• Brand Name: AMSCO 7053L 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: 17499890
• Report Number: 9680353-2023-00030
• Device Sequence Number: 6796476
• Product Code: MEC
• UDI-Device Identifier: 00724995193119
• UDI-Public: 00724995193119
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 08/10/2023

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: 07/13/2023
• Initial Report FDA Received Date: 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2019
• 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