MAUDE Adverse Event Report: STERIS CANADA ULC 6000 SERIES RELIANCE ENDOSCOPE DRYING AND STORAGE CABINET; ENDOSCOPE DRYING CABINET

Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	01/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the drying cabinet and found that the back edges of the doorframe on the side of the hinge were sharp resulting in the reported event.While onsite the technician filed down the edges, tested the unit, confirmed it to be operational, and returned it to service.No additional issues have been reported.
Event or Problem Description
The user facility reported that an employee obtained a cut on their hand while cleaning their 6000 series reliance endoscope drying and storage cabinet.No medical treatment was sought or administered.

• Brand Name: 6000 SERIES RELIANCE ENDOSCOPE DRYING AND STORAGE CABINET
• Common Device Name: ENDOSCOPE DRYING CABINET
• Manufacturer (Section D): STERIS CANADA ULC; 490 boulevard armand-paris; quebec, G1C 8 A3; CA G1C 8A3
• Manufacturer (Section G): STERIS CANADA ULC; 490 boulevard armand-paris; quebec, G1C 8 A3; CA G1C 8A3
• Manufacturer Contact: daniel davy ; 5960 heisley rd; mentor, OH 44060 ; 4403927453
• MDR Report Key: 18669487
• Report Number: 9680353-2024-00007
• Device Sequence Number: 7819776
• Product Code: PUP
• UDI-Device Identifier: 00724995168124
• UDI-Public: 00724995168124
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 02/08/2024
• 2 Devices were Involved in the Event: 1 2

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
• 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: 01/12/2024
• Supplement Date Received by Manufacturer: 01/12/2024
• Initial Report FDA Received Date: 02/08/2024
• Supplement Report FDA Received Date: 04/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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