MAUDE Adverse Event Report: STERIS CANADA CORPORATION RELIANCE VISION WASHER

Device Problems Fire (1245); Smoking (1585)

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

Event Date 10/29/2018

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite following the reported event to inspect the reliance vision washer and found that one of the drying elements located within the washer was broken.The drying element is an electric heater that heats up the circulating air in the washer to dry the instruments.The drying element had melted causing the reported event.The technician was informed that the user facility's reliance vision washer is a high usage unit and runs 18-20 hours a day.The technician replaced the drying element, ran a test cycle, and found the unit operating according to specification.The washer has been returned to service.A 3-year complaint review indicates this to be an isolated event and no additional issues have been reported.

Event Description

The user facility reported their reliance vision washer was smoking and a small flame was observed within the chamber of the washer.No report of injury.No evacuation was required.

• Brand Name: RELIANCE VISION 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: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 8112372
• MDR Text Key: 128869059
• Report Number: 9680353-2018-00087
• 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: 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/29/2018
• 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