MAUDE Adverse Event Report: STERIS CANADA CORPORATION RELIANCE SYNERGY WASHER/DISINFECTOR

Device Problem Difficult to Open or Close (2921)

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

Event Date 10/20/2015

Event Type  No Answer Provided  

Manufacturer Narrative

A review of service records indicates the user facility has one reliance synergy washer; the last service activity was performed by steris in 2010.The steris account manager contacted the user facility on multiple occasions to discuss the reported event however, the user facility will not respond.The operator manual states (pp.1-1), "repairs and adjustments to this equipment must be made only by steris or steris-trained service personnel.Repairs and adjustments performed by unqualified personnel or installation of unauthorized parts could cause personal injury, result in improper equipment performance, void the warranty or result in costly damage.Contact steris regarding service options." a follow-up report will be submitted should additional information become available.

Event Description

The user facility reported via medwatch 4913020000-2015-8003 that the doors on their reliance synergy washer would not open.

• Brand Name: RELIANCE SYNERGY WASHER/DISINFECTOR
• Type of Device: WASHER/DISINFECTOR
• 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: 5261401
• MDR Text Key: 32536421
• Report Number: 9680353-2015-00084
• 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: 12/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Initial Date Manufacturer Received: 11/03/2015
• Initial Date FDA Received: 12/02/2015
• 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