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

Device Problem Difficult to Advance (2920)

Patient Problem Pain (1994)

Event Date 10/24/2023

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 329558686
• Report Number: 9680353-2023-00038
• Device Sequence Number: 1
• Product Code: MEC
• UDI-Device Identifier: 00724995176570
• UDI-Public: 00724995176570
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2023
• Initial Date FDA Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1