MAUDE Adverse Event Report: CORPORATION STERIS CANADA RELIANCE VISION; WASHER/DISINFECTOR

Model Number	MULTI-CHAMBER
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that an employee was handling a rack to their reliance vision multi-chamber washer/disinfector and obtained an injury to their finger.The employee sought and received medical treatment (x-ray).
Additional Manufacturer Narrative
User facility personnel stated that the employee subject of the reported event was addressing alarm#110: sonic chamber rack not moving.When the employee was addressing the alarm, she was handling the rack and, in the process, injured her finger.A steris service technician arrived onsite following the event and found that the air cylinder of the rack stopper mechanism was stuck in position.As the rack stopper mechanism was stuck in position, it stopped the rack from moving into the rinse chamber of the washer/disinfector causing the alarm#110.The operator manual states the following instructions for alarm# 110, "rack does not reach its proper position within rinse chamber once process within sonic chamber is completed.1.Press alarm reply to silence buzzer and acknowledge alarm.2.Try to resume cycle.3.If situation reoccurs, contact steris." the technician repaired the unit, tested the function and operation of the device, confirmed it to be operating according to specifications, and returned it to service.The technician counseled user facility personnel on the importance of following instructions for acknowledging alarms.A three-year complaint review confirmed the reported event to be isolated.No additional issues have been reported.

• Brand Name: RELIANCE VISION
• Common Device Name: WASHER/DISINFECTOR
• Manufacturer (Section D): CORPORATION STERIS CANADA; 490 boulevard armand-paris; quebec, G1C 8 A3; CA G1C 8A3
• Manufacturer (Section G): CORPORATION STERIS CANADA; 490 boulevard armand-paris; quebec, G1C 8 A3; CA G1C 8A3
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4402597401
• MDR Report Key: 22912611
• Report Number: 9680353-2025-00035
• Device Sequence Number: 21096187
• Product Code: MEC
• UDI-Device Identifier: 00724995193294
• UDI-Public: (01)00724995193294(11)201006
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 08/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: MULTI-CHAMBER
• Device Catalogue Number: FH94062
• 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: 07/29/2025
• Initial Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2020
• 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