MAUDE Adverse Event Report: CORPORATION STERIS CANADA RELIANCE; RELIANCE ENDOSCOPE DRYING AND STORAGE CABINET

Model Number	6000 SERIES
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	06/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that an employee was cleaning the chamber of their reliance endoscope drying and storage cabinet and obtained a small cut to their hand.The employee did not seek or receive medical treatment and continued working.
Additional Manufacturer Narrative
A steris service technician contacted the user facility following the reported event.The user facility's biomedical technician stated he would perform necessary service activity on the reliance endoscope drying and storage cabinet and declined steris's service.The reliance endoscope drying and storage cabinet is not under a steris service agreement; all routine and preventive maintenance activities are performed by the user facility's biomedical technicians.No additional issues have been reported.

• Brand Name: RELIANCE
• Common Device Name: RELIANCE ENDOSCOPE DRYING AND STORAGE CABINET
• 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
• MDR Report Key: 22529487
• Report Number: 9680353-2025-00026
• Device Sequence Number: 7487792
• Product Code: PUP
• UDI-Device Identifier: 00724995168100
• UDI-Public: (01)00724995168100
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Report Date (Section B): 07/17/2025

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: 6000 SERIES
• Device Catalogue Number: REC6102DS
• 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: 06/20/2025
• Initial Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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