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

Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the amsco 7052hp washer/disinfector.The technician found that the subject rack was not loaded properly and had become unseated from the sliding guide within the unit's chamber.No issues were noted with the function or operation of the amsco 7052hp washer/disinfector.The steris technician further inspected the unit's conveyor system and found it to be lower than amsco 7052hp washer/disinfector rack's sliding guide; the conveyor system should be level with the unit's sliding guide.The steris technician adjusted the level of the conveyor system and proactively adjusted the unload door switch on the amsco 7052hp washer/disinfector.The technician ran a test cycle and confirmed the amsco 7052hp washer/disinfector and conveyor system were operating properly.The steris technician returned the amsco 7052hp washer/disinfector to service and no additional issues have been reported.A complaint review was conducted, and the reported event is considered to be isolated.
Event or Problem Description
The user facility reported that an employee obtained an injury (shoulder muscle strain) while unloading a rack that was jammed inside their amsco 7052hp washer/disinfector.No medical treatment was sought or administered.

• 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: 18133172
• Report Number: 9680353-2023-00038
• Device Sequence Number: 18090251
• Product Code: MEC
• UDI-Device Identifier: 00724995176570
• UDI-Public: 00724995176570
• 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): 11/14/2023

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: 10/24/2023
• Initial Report FDA Received Date: 11/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2023
• 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