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

Model Number	RELIANCE 6500
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of this event is currently in progress.A follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that the door to their 6000 series reliance endoscope drying and storage cabinet fell off while an employee was retrieving a scope.No report of injury.

• Brand Name: RELIANCE
• Common Device Name: DRYING AND STORAGE CABINET
• Manufacturer (Section D): STERIS CORPORATION; 6100 heisley rd; mentor OH 44060
• Manufacturer (Section G): STERIS CORPORATION; 6100 heisley rd; mentor OH 44060
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4402597401
• MDR Report Key: 23923667
• Report Number: 3003950207-2025-00013
• Device Sequence Number: 15706416
• Product Code: PUP
• UDI-Device Identifier: 00724995229528
• UDI-Public: (01)00724995229528(11)241129
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 12/30/2025

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: RELIANCE 6500
• Device Catalogue Number: REL650012EM
• 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: 12/01/2025
• Initial Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown