MAUDE Adverse Event Report: STERIS CANADA ULC RELIANCE EPS; ENDOSCOPE PROCESSING SYSTEM

Model Number	EPS
Medical Device Problem Code	Device Emits Odor (1425)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the reliance eps and found that the overtemperature switch, fuse, and connecting wires were damaged.A few days prior to the reported event, a steris technician inspected the unit as it displayed an alarm and found that the detergent container was not properly attached causing detergent to leak within the unit.The technician reattached the detergent container, cleaned up the chemistry and returned the unit to service.It is likely that the reported event is attributed to damage to the overtemperature switch from the leaking detergent.The technician made the necessary repairs, tested the unit, confirmed it to be operating according to specification, and returned it to service.A 3-year complaint review indicates this to be an isolated event.No additional issues have been reported.
Event or Problem Description
The user facility reported smoke was emitting from their reliance endoscope processor.No report of injury.

• Brand Name: RELIANCE EPS
• Common Device Name: ENDOSCOPE PROCESSING SYSTEM
• 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 road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 14162233
• Report Number: 9680353-2022-00014
• Device Sequence Number: 14901764
• Product Code: NZA
• UDI-Device Identifier: 00724995152178
• UDI-Public: 00724995152178
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/20/2022

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
• Device Model Number: EPS
• Device Catalogue Number: MB3
• 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: 03/25/2022
• Initial Report FDA Received Date: 04/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2019
• 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