MAUDE Adverse Event Report: STERIS CANADA CORPORATION RELIANCE 777 WASHER

Device Problem Fluid/Blood Leak (1250)

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

Event Date 11/25/2014

Event Type  No Answer Provided  

Event Description

The user facility reported their sterilizer was leaking water.No injuries or procedural delays or cancellations were reported.

Manufacturer Narrative

A steris field service technician arrived onsite, inspected the washer, and identified the user facility had already replaced the strainer on the pre-wash chamber.The user facility reported the leak was caused by the original strainer which was worn.The technician examined the worn strainer and identified a crack which caused the leak.The customer requested the steris technician inspect the washer's strainer replacement.The technician inspected the unit, ran several tests, and confirmed the unit to be operating according to specification.

• Brand Name: RELIANCE 777 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: 4356444
• MDR Text Key: 5199378
• Report Number: 9680353-2014-00097
• 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
• Report Date: 12/23/2014

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: 11/25/2014
• Initial Date FDA Received: 12/23/2014
• 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