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

Device Problem Obstruction of Flow (2423)

Patient Problem No Information (3190)

Event Date 02/15/2017

Event Type  malfunction  

Manufacturer Narrative

During the time of the reported event the employee was manually pushing the manifold rack into the washer due to an obstruction when the chamber door came down.The employee subject of the reported event did not follow proper procedure for a washer door obstruction as stated in the reliance vision single chamber washer operator manual.The operator manual states (pp.1-2), "if an obstruction is present in chamber door, do not attempt to remove the object.Door automatically raises and remains open.Hot water and steam may be sprayed through door opening.Always wear appropriate personal protective equipment (ppe) and wait for water flow to stop." a steris service technician arrived onsite to inspect the washer and found the unit to be operating properly.No issues were noted with the function or operation of the washer and the safety bar was found to be operating properly.The technician ran a test cycle and returned the washer to service.No additional issues have been reported.Steris offered in-service training on the proper use and operation of the washer and the user facility accepted.

Event Description

The user facility reported that an employee was removing an obstruction from the washer and in the process the door made contact with the employee's hand.The user facility declined to provide information regarding if the employee sought or received medical treatment.

• Brand Name: RELIANCE VISION SINGLE CHAMBER WASHER
• Type of Device: WASHER
• Manufacturer (Section D): STERIS CANADA CORPORATION; 490 armand-paris; quebec, quebec GIC 8 A3; CA GIC 8A3
• Manufacturer (Section G): STERIS CANADA CORPORATION; 490, armand-paris; quebec, quebec GIC 8 A3; CA GIC 8A3
• Manufacturer Contact: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 6407729
• MDR Text Key: 70305962
• Report Number: 9680353-2017-00020
• 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
• Type of Report: Initial
• Report Date: 03/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/16/2017
• 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