MAUDE Adverse Event Report: STERIS CANADA CORPORATION RELIANCE SYNERGY WASHER

Device Problems Device Inoperable (1663); Difficult to Open or Close (2921)

Patient Problem Injury (2348)

Event Date 10/16/2014

Event Type  No Answer Provided  

Event Description

The user facility reported their reliance synergy washer doors were not closing and the automated transport system attached to the washer was not functioning properly.An employee experienced a back strain while moving the manifold rack manually onto the automated transport system.The employee subject of the reported event sought medical treatment but has returned to normal work duties.No procedural delays or cancellations were reported.

Manufacturer Narrative

A steris field service technician arrived onsite, inspected the washer and transport system, and identified an active door obstruction alarm on the washer's loading side.The automated transport system was not pushing the rack manifolds completely into the washer's chamber.This caused the door obstruction alarm to activate thus preventing the washer doors from closing.The technician observed the puller/pusher mechanism was not making full contact with the rolling cylinders.The technician re-adjusted the automated transport system, tested the unit and system, and returned both to service according to specification.

• Brand Name: RELIANCE SYNERGY WASHER
• Type of Device: WASHER
• Manufacturer (Section D): STERIS CANADA CORPORATION; 490 armand-paris; quebec, quebec GIC 8A3; CA GIC 8A3
• Manufacturer (Section G): STERIS CANADA CORPORATION; 490, armand-paris; quebec, quebec GIC 8A3; CA GIC 8A3
• Manufacturer Contact: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 4246195
• MDR Text Key: 4987269
• Report Number: 9680353-2014-00094
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/12/2014

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/16/2014
• Initial Date FDA Received: 11/12/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/20/2015
• 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