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

Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that their reliance vision single-chamber washer/disinfector was emitting smoke.No report of injury.
Additional Manufacturer Narrative
Our investigation is currently in process.A follow-up mdr will be submitted once additional information becomes available.
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the unit.The technician found that the internal hose that supplies lubricant was leaking onto the heating elements and insulation located underneath resulting in the reported event.The technician made the necessary repairs, tested the unit, confirmed it to be operating according to specifications, and returned it to service.The unit is not under steris service agreement for maintenance activities.The user facility is responsible for all maintenance activities.A 3-year complaint review indicates this to be an isolated event.No additional issues have been reported.

• Brand Name: RELIANCE VISION SINGLE-CHAMBER WASHER/DISINFECTOR
• Common Device Name: 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: 19280643
• Report Number: 9680353-2024-00016
• Device Sequence Number: 17726364
• Product Code: MEC
• UDI-Device Identifier: 00724995192648
• UDI-Public: 00724995192648
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2024

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
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown