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

Model Number	RELIANCE 6500
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/17/2025
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.Udi related data clarification - the lot/serial number is unknown, therefore, the applicable production identifiers were not included in the mdr.
Event or Problem Description
The user facility reported that while an employee was opening their 6500 series reliance endoscope drying and storage cabinet, a scope holder component detached and fell to the base of the cabinet.While bending to retrieve the fallen component, an endoscope ultrasound adaptor with its holder fell from the cabinet and contacted the employee's head resulting in an injury.Medical treatment was sought; it is unknown if medical treatment was administered.

• Brand Name: RELIANCE
• Common Device Name: ENDOSCOPE DRYING AND STORAGE CABINET
• Manufacturer (Section D): STERIS CORPORATION; 6100 heisley road; mentor OH 44060
• Manufacturer (Section G): STERIS CORPORATION; 6100 heisley road; mentor OH 44060
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4402597401
• MDR Report Key: 24094387
• Report Number: 3003950207-2026-00001
• Device Sequence Number: 10468707
• Product Code: PUP
• UDI-Device Identifier: 00724995229504
• UDI-Public: (01)00724995229504
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 01/16/2026

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: RELIANCE 6500
• Device Catalogue Number: REL650012MU
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 01/16/2026
• 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