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

Device Problem Difficult to Open or Close (2921)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/05/2016

Event Type  No Answer Provided  

Manufacturer Narrative

Following the event a steris technician arrived at the facility, inspected the reliance vision washer/disinfector and found damage on the cable door assembly.The cables were bare and created shorts in the electrical circuit, which shut the washer down.The shorts also caused the solenoid valve and door switch to fail.The damage was caused by the improper orientation of the cable door assembly.The dhr was reviewed and no issues were noted.The cable door assembly is tested during manufacturing for proper operation and again during final testing.No issues were noted during manufacturing and final testing.When the washer was installed no issues were noted with the cable door assembly.During the steris technician's inspection of the washer he was unable to determine the cause of the improper orientation of the cable door assembly.The technician replaced the cable door assembly, door switch, pneumatic valve, and ran a full test cycle.The unit was found operational and returned to service.No additional issues have been reported.

Event Description

The user facility reported that the unload door of the reliance vision single chamber washer/disinfector would not open.No report of injury however, procedure delays occurred due to the reported event.

• 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: 6223048
• MDR Text Key: 64172827
• Report Number: 9680353-2017-00001
• 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
• Type of Report: Initial
• Report Date: 01/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/05/2016
• Initial Date FDA Received: 01/04/2017
• 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