MAUDE Adverse Event Report: STERIS CANADA CORPORATION RELIANCE VISION SINGLE CHAMBER WASHER

Device Problem Difficult to Remove (1528)

Patient Problem Abrasion (1689)

Event Date 08/10/2020

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived on site to inspect the reliance vision single chamber washer and found that the door assembly needed replaced.The reliance vision single chamber washer operator manual states (1-1), "risk of pinch point." the operator manual further states (1-2), "if an obstruction is present in chamber door, do not attempt to remove the object." the technician replaced the vision sc door assembly, tested the unit, found it to be operational, and returned it to service.A steris account manager counseled the facility on the importance of keeping their hands away from the door while closing.No additional issues have been reported.

Event Description

The user facility reported that an employee obtained a hand injury from the chamber door when attempting to dislodge a rack while loading their reliance vision single chamber washer.The employee sought medical treatment in the er for a hand abrasion.

• Brand Name: RELIANCE VISION SINGLE CHAMBER WASHER
• Type of Device: WASHER
• Manufacturer (Section D): STERIS CANADA CORPORATION; 490 armand-paris; quebec, GIC 8 A3; CA GIC 8A3
• Manufacturer (Section G): STERIS CANADA CORPORATION; 490, armand-paris; quebec, GIC 8 A3; CA GIC 8A3
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 10541487
• MDR Text Key: 210460381
• Report Number: 9680353-2020-00025
• Device Sequence Number: 1
• Product Code: MEC
• 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: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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