MAUDE Adverse Event Report: STERIS CORPORATION RELIANCE; 6500 SERIES RELIANCE ENDOSCOPE DRYING AND STORAGE CABINET

Model Number	RELIANCE 6500
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Head Injury (1879)
Date of Event	04/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the hook to their 6500 series reliance endoscope drying and storage cabinet contacted the employee's head.It is unknown if medical treatment was sought or administered.
Additional Manufacturer Narrative
Investigation of the reported event is in progress; a follow-up report will be submitted when additional information becomes available.

• Brand Name: RELIANCE
• Common Device Name: 6500 SERIES RELIANCE 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: 25046610
• Report Number: 3003950207-2026-00012
• Device Sequence Number: 9921328
• Product Code: PUP
• UDI-Device Identifier: 00724995229504
• UDI-Public: (01)00724995229504(11)250303
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/30/2026

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: 04/01/2026
• Initial Report FDA Received Date: 04/30/2026
• Date Device Manufactured: 03/03/2025
• 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