MAUDE Adverse Event Report: CORPORATION STERIS CANADA AMSCO; AMSCO 7052HP WASHER-DISINFECTOR

Model Number	7052HP
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the unit and found no issues with the function or operation of the unit or the door.No repairs were required and the unit was returned to service.A steris account manager offered in-service training to user facility personnel on the proper use and operation of their amsco 7052hp washer/disinfector, and is pending a response.No additional issues have been reported.
Event or Problem Description
The user facility reported an employee "obtained an injury while using the load side door" to their amsco 7052hp washer/disinfector.No details on the nature or extent of the alleged injury was provided.It is unknown if medical treatment was sought or administered.
Additional Manufacturer Narrative
A steris account manager conducted in-service training with user facility personnel on the proper use and operation of their amsco 7052hp washer/disinfector, specifically, on proper loading techniques.No additional issues have been reported.Product problem was incorrectly selected in mdr.This has been correctly updated to adverse event.

• Brand Name: AMSCO
• Common Device Name: AMSCO 7052HP WASHER-DISINFECTOR
• Manufacturer (Section D): CORPORATION STERIS CANADA; 490 boulevard armand-paris; quebec, G1C 8 A3; CA G1C 8A3
• Manufacturer (Section G): CORPORATION STERIS CANADA; 490 boulevard armand-paris; quebec, G1C 8 A3; CA G1C 8A3
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 20796754
• Report Number: 9680353-2024-00041
• Device Sequence Number: 7894953
• Product Code: MEC
• UDI-Device Identifier: 00724995176570
• UDI-Public: (01)00724995176570(11)210712
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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,Followup
• Report Date (Section B): 11/27/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 7052HP
• Device Catalogue Number: FH18072
• 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: 10/31/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2021
• 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