MAUDE Adverse Event Report: STERIS CANADA ULC AMSCO 7053HP WASHER/DISINFECTOR

Device Problem Mechanical Jam (2983)

Patient Problem Abrasion (1689)

Event Date 12/20/2023

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the washer and found it to be operating per specifications and no repairs were required.While onsite, the technician learned that a user scraped their hand while attempting to manually clear obstruction from the washer door.The root cause of the event was determined as user error as the employee should not have manually cleared the obstruction from the washer door.The amsco 7053hp washer operator manual states (1-2) "safety precautions if an obstruction is present in the wash chamber door, the door safety bar will detect an obstruction and the door will automatically stop from closing.Wait until door is fully open before removing obstruction." the steris service technician counseled user facility personnel on proper loading techniques and safety operation protocols.No additional issues have been reported.

Event Description

The user facility reported that an employee scraped their hand on washer door after pushing a jammed rack into a amsco 7053hp washer.The user facility did not disclose if any medical treatment was sought or administered to facility personnel.

• Brand Name: AMSCO 7053HP 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: 18536738
• MDR Text Key: 333548841
• Report Number: 9680353-2024-00005
• Device Sequence Number: 1
• Product Code: MEC
• UDI-Device Identifier: 00724995176662
• UDI-Public: 00724995176662
• 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: 01/18/2024

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2023
• Initial Date FDA Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2022
• 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