MAUDE Adverse Event Report: STERIS CANADA ULC RELIANCE VISION SINGLE CHAMBER WASHER/DISINFECTOR

Device Problems Fire (1245); Smoking (1585)

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

Event Date 05/31/2023

Event Type  malfunction  

Event Description

The user facility reported that a small fire was observed emitting from the top of their reliance vision single chamber washer/disinfector.The fire was extinguished, and no injuries were reported.

Manufacturer Narrative

A steris service technician inspected the reliance vision single chamber washer/disinfector and found that the light housing inside the unit's chamber was cracked.As the light housing was damaged, water may have penetrated the light assembly subsequently causing a short circuit to occur followed by the reported small fire.The steris service technician replaced and repaired the damaged components, ran a test cycle, and confirmed the unit to be operational.The reliance vision single chamber washer/disinfector was returned to service and no additional issues have been reported.

Manufacturer Narrative

Through follow-up with user facility personnel, the steris service technician learned that contrary to the initial report there was no fire, only smoke emitting from the top of the washer.At the time of the event, a user facility employee found a smoldering rag on top of the washer's chamber.The user facility employee removed the rag, placed it in a sink, and rinsed it with water.Three scheduled surgery cases were postponed as a result of the reported event.A technician was dispatched to the facility and arrived onsite the same day to inspect the washer.The technician inspected the washer and found evidence of charring on the wiring of the light ballast and some of the surrounding components.The technician also found that the silicone seal at the top of the light assembly was damaged (cracked).As the silicone seal was cracked, this may have allowed hot and humid air to leak onto the light ballast causing an electrical short resulting in the reported event.The event was very likely exacerbated by the rag that had been inadvertently left on top of the chamber.The damaged washer components were not returned for evaluation, therefore, an exact cause of the crack on the silicone seal for the light assembly could not be determined.The washer was installed in 2012 making it approximately 11 years old at the time of the event.The washer is under steris service agreement for maintenance activities.The last maintenance visit prior to the reported event was completed on january 27, 2023; no issues with the light assembly were identified at that time.The reliance vision single-chamber washer/disinfector is designed with fire-resistant materials including fire-retardant insulation on the top panel.The rag that was found smoldering at the top of the washer's chamber near the light ballast likely contributed to the observed smoke.Based on discussion with user facility personnel, we were unable to determine the origin of the rag.To address the issue, the technician replaced the light assembly, tested the washer, confirmed it to be operating according to specification, and returned it to service.No additional issues have been reported.

• Brand Name: RELIANCE VISION SINGLE CHAMBER WASHER/DISINFECTOR
• Type of Device: WASHER/DISINFECTOR
• Manufacturer (Section D): STERIS CANADA ULC; 490 boulevard armand-paris; quebec, G1C 8 A3; CA G1C 8A3
• Manufacturer (Section G): STERIS CANADA ULC; 490 boulevard armand-paris; quebec, G1C 8 A3; CA G1C 8A3
• Manufacturer Contact: daniel davy ; 5960 heisley rd; mentor, OH 44060 ; 4403927453
• MDR Report Key: 17238726
• MDR Text Key: 318200779
• Report Number: 9680353-2023-00023
• 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: 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2023
• 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: 05/31/2023
• 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