MAUDE Adverse Event Report: STERIS CORPORATION RELIANCE; DRYING CABINET

Model Number	RELIANCE 6500
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Codes	Laceration(s) (1946); Insufficient Information (4580)
Date of Event	09/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of the reported event is in progress.A follow-up report will be submitted once additional information becomes available.
Event or Problem Description
The user facility reported that an employee obtained an injury from the sharp edges of the drip pan of their 6500 series hepa drying cabinet.The employee did not seek medical treatment and continued working.
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the unit and confirmed the sharp edges.To resolve the issue, the appropriate repairs were completed.The unit was tested, confirmed to be operating according to specification, and returned to service.A 3-year complaint review indicates this to be an isolated event.No additional issues have been reported.
Event or Problem Description
The user facility reported that an employee obtained a metal splinter after contacting a sharp edge of the drip pan of their 6500 series hepa drying cabinet.The employee sought medical treatment and the splinter was removed.

• Brand Name: RELIANCE
• Common Device Name: DRYING 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 ; 4403927453
• MDR Report Key: 23324610
• Report Number: 3003950207-2025-00009
• Device Sequence Number: 21485917
• Product Code: PUP
• UDI-Device Identifier: 00724995229511
• UDI-Public: (01)00724995229511(11)250425
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2025

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: RELIANCE 6500
• Device Catalogue Number: REL650020MU
• 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: 09/18/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2025
• 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