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

Device Problem Smoking (1585)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/27/2020

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the washer and found the root cause of the reported event is attributed to the drying elements.The drying elements overheated resulting in the reported event.The washer was installed in 2014 and is under steris service agreement for maintenance activities.The last maintenance was performed on (b)(6) 2020.No issues with the function or operation of the washer were identified at that time; the unit was operating according to specification.The technician performed the necessary repairs, tested the unit, confirmed it to be operating according to specifications, and returned it to service.No additional issues have been reported.

Event Description

The user facility reported that smoke was emitting from their reliance vision single chamber washer.The department was evacuated, and the fire department was dispatched.No report of injury.No report of fire.

• Brand Name: RELIANCE VISION SINGLE CHAMBER WASHER
• Type of Device: WASHER
• Manufacturer (Section D): STERIS CANADA CORPORATION; 490 armand-paris; quebec, GIC 8 A3; CA GIC 8A3
• Manufacturer (Section G): STERIS CANADA CORPORATION; 490, armand-paris; quebec, GIC 8 A3; CA GIC 8A3
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 10839862
• MDR Text Key: 217691308
• Report Number: 9680353-2020-00035
• 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: 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• 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
• Date Manufacturer Received: 10/27/2020
• 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