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

Device Problems Failure to Sense (1559); Device Operates Differently Than Expected (2913)

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

Event Date 10/12/2015

Event Type  No Answer Provided  

Manufacturer Narrative

Steris monitors relevant websites and social media sources per our social media policy to identify potential complaints.Through this process, steris identified an anonymous post reporting that after the door on their reliance vision single chamber washer closed, the sensor was not able to detect the closed door to begin a cycle.The reported event stated in the social media post may be the result of a damaged door lock assembly.If the sensor does not indicate that the door is closed, it will prevent the initiation of a cycle.Steris responded and provided contact information including a phone number however; steris has not received a response.Based on the information provided in the anonymous post this event appears to meet our reporting criteria for medical devices.A follow up report will be submitted if additional information becomes available.

Event Description

The complainant reported the door on their reliance vision single chamber washer was not operating properly.The complainant stated, "the door open/closed sensor on the load side doesn't sense the door is closed and will not allow a cycle to be started.Is there a way to bypass this so the washer can be used while we are waiting for repair?".

• 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: 5219012
• MDR Text Key: 31129655
• Report Number: 9680353-2015-00075
• Device Sequence Number: 1
• Product Code: MEC
• Combination Product (y/n): N
• 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: 11/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2015
• Was Device Evaluated by Manufacturer?: No
• 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