MAUDE Adverse Event Report: STERIS CANADA ULC AMSCO 5052 WASHER/DISINFECTOR

Model Number 5052

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Abrasion (1689)

Event Date 06/08/2023

Event Type  malfunction  

Event Description

The user facility reported that an employee obtained a cut on their finger while operating their amsco 5052 washer.Medical treatment was sought and administered.

Manufacturer Narrative

A steris service technician arrived onsite to inspect the amsco 5052 washer/disinfector and found it to be operating properly.No repairs were required, and the unit was returned to service.The amsco 5052 washer/ disinfector operator manual states (1-1), "warning - personal injury hazard: risk of pinch point between door and threshold when the door opens.Keep fingers away from threshold." the steris account manager offered in-service training on the proper use and operation of the amsco 5052 washer/disinfector; however, the customer declined the in-service training.No additional issues have been reported.

• Brand Name: AMSCO 5052 WASHER/DISINFECTOR
• Type of Device: 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: 17343546
• MDR Text Key: 320156367
• Report Number: 9680353-2023-00027
• Device Sequence Number: 1
• Product Code: MEC
• UDI-Device Identifier: 00724995152062
• UDI-Public: 00724995152062
• 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: 07/18/2023

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
• Device Model Number: 5052
• Device Catalogue Number: FH14
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/19/2023
• Initial Date FDA Received: 07/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2019
• 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