MAUDE Adverse Event Report: STERIS CANADA ULC RELIANCE VISION SINGLE CHAMBER WASHER/DISINFECTOR

Device Problem Mechanical Jam (2983)

Patient Problem Bruise/Contusion (1754)

Event Date 12/15/2022

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the reliance vision single chamber washer.The technician found that during the unloading process the unload door of the washer became jammed by the rack while being closed.The employee subject of the reported event attempted to free the rack manually by pushing it into the unit.The door began to close and pinched her hand between the door and the rack resulting in the reported event.She was able to pull her hand out and the door retracted.The reliance vision single chamber washer operator manual states, "if an obstruction is present in chamber door, do not attempt to remove the object." the reliance vision single chamber washer operator manual states, "warning - personal injury hazard: when doors are closing, a pinch point is created at hinges.Keep fingers away from door hinges to prevent pinching." the technician tested the door's safety bar and the operation and function of the unit.The technician found the unit to be operating according to specifications and returned it to service; no repairs were required.The technician counseled the user facility on the proper operation of the reliance vision single chamber washer, specifically, they should not attempt to manually clear a rack while the door is moving.No additional issues have been reported.

Event Description

The user facility reported that while unloading their reliance vision single chamber washer/disinfector a rack became jammed and an employee sustained cuts and bruises to their hand, as a result of attempting to free the rack manually.The employee was sent to the er at the user facility and was given an x-ray.The employee sustained superficial bruising and treated with a bandage.

• Brand Name: RELIANCE VISION SINGLE CHAMBER 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 road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 16147843
• MDR Text Key: 308499677
• Report Number: 9680353-2023-00002
• Device Sequence Number: 1
• Product Code: MEC
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2023
• 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
• Date Manufacturer Received: 12/15/2022
• 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