MAUDE Adverse Event Report: STERIS CANADA CORPORATION RELIANCE VISION WASHER

Device Problems Device Emits Odor (1425); Smoking (1585); Sparking (2595)

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

Event Date 11/11/2019

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived on site following the reported event to inspect the reliance vision washer and found evidence of charring and the wiring around the light assembly was melted.Based on the technicians inspection, the root cause of the reported event can be attributed to the light ballast.The ballast is part of the lighting assembly and acts as a regulator that controls the electrical current to the light.The ballast had short-circuited, causing the light to spark and the reported event to occur.The reliance vision washer is under steris service agreement for maintenance activities and was installed in july 2010 making the unit approximately 9 years old at the time of the reported event.The last preventive maintenance was performed by steris in october 2019.At this time, the washer was found to be operating according to specification.No issues with the function or operation of the unit were identified.The technician replaced the unit's light assembly and ballast, ran several test cycles and found the washer to be operating according to specification.No additional issues have been reported.

Event Description

The user facility reported a burning smell coming from their reliance vision washer.They opened the top of the washer and observed sparking and smoke.The user facility immediately shut off the power to the unit.No report of injury.

• Brand Name: RELIANCE VISION 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: 9417616
• MDR Text Key: 176032135
• Report Number: 9680353-2019-00049
• 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: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• 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: 11/11/2019
• 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