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

Model Number	SINGLE CHAMBER
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	03/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician was onsite performing unrelated service activity on another unit, when he was informed of the reported event.The technician inspected the reliance vision single-chamber washer/disinfector and found the obstruction bar to be missing from the load door.The technician instructed user facility personnel that the reliance vision single-chamber washer/disinfector should not operate without the obstruction bar.The technician replaced the door assembly which included restoring the obstruction bar functionality, tested the function and operation of the reliance vision single-chamber washer/disinfector, confirmed it to be operating to specification and returned it to service.The reliance vision single-chamber washer/disinfector is under a steris maintenance agreement.During the previous preventive maintenance activity prior to the reported event, it was confirmed that the obstruction bar was present and operating to specifications.User facility personnel could not provide information to the steris service technician regarding why the obstruction bar was missing or who removed it.The technician counseled user facility personnel on the proper user and operation for the reliance vision single-chamber washer/disinfector and the importance of the obstruction bar.No additional issues have been reported.
Event or Problem Description
The user facility reported that an employee obtained an injury (broken finger) when the door to their reliance vision single-chamber washer/disinfector contacted their hand.The employee sought and received medical treatment at the facility's emergency room.

• 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: 24913264
• Report Number: 9680353-2026-00019
• Device Sequence Number: 9874776
• Product Code: MEC
• UDI-Device Identifier: 00724995192686
• UDI-Public: (01)00724995192686(11)191209
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 04/17/2026

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: SINGLE CHAMBER
• Device Catalogue Number: FH05072
• 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: 03/18/2026
• Initial Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2019
• 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