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

Model Number 5052

Device Problem Use of Device Problem (1670)

Patient Problem Pain (1994)

Event Date 03/01/2023

Event Type  malfunction  

Event Description

The user facility reported that as an employee was unloading their amsco 5052 washer/disinfector, the door of the unit closed on the employee's hand resulting in an injury.Medical treatment was sought and administered, and the employee returned to work.

Manufacturer Narrative

A steris service technician arrived onsite to inspect the amsco 5052 washer/disinfector and found it to be operating according to specification.The technician stated that the door was functioning normally and closing at the correct speed.The technician also found that there were no issues with the function of the door safety switches.No repairs were required, and the unit was returned to service.The reported event is attributed to user error as the employee should have ensured that their hand was away from the unit's threshold when the door of the unit was closing.A steris account manager conducted in-service training with user facility personnel on the proper use and operation of the amsco 5052 washer/disinfector, specifically on safe operating protocols.No additional issues have been reported.

• Brand Name: AMSCO 5052 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: 16638068
• MDR Text Key: 312305953
• Report Number: 9680353-2023-00008
• Device Sequence Number: 1
• Product Code: MEC
• UDI-Device Identifier: 00724995192976
• UDI-Public: 00724995192976
• 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: 03/29/2023

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: FH14072
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2023
• Initial Date FDA Received: 03/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2019
• 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