MAUDE Adverse Event Report: STERIS CORPORATION RELIANCE; ENDOSCOPE DRYING/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	10/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported the chamber door to their 6500 series reliance endoscope drying and storage cabinet detached while an employee was unloading the chamber.No report of injury.
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the 6500 series reliance endoscope drying and storage cabinet and found the top door hinge assembly to the chamber door was dislodged and resulted in the reported event.The technician replaced all door hinges to the chamber door.The unit was tested, confirmed to be operating according to specification, and returned to service.The device history record for the unit was reviewed and confirmed the unit was manufactured to specifications; no abnormalities were noted.A 3-year complaint review indicates this to be an isolated event.No additional issues have been reported.

• Brand Name: RELIANCE
• Common Device Name: ENDOSCOPE DRYING/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: 23708653
• Report Number: 3003950207-2025-00011
• Device Sequence Number: 10628888
• Product Code: PUP
• UDI-Device Identifier: 00724995229504
• UDI-Public: (01)00724995229504(11)250203
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 12/03/2025

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: REL650012MU
• 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: 11/03/2025
• Initial Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2025
• 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