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

Model Number	6000 SERIES
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	08/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris account manager arrived on-site to inspect the unit.The account manager confirmed the presence of slightly rough edge on the outer seam of the drying cabinet near the door.While not in a common path for a user during normal use of the cabinet, it is possible that while cleaning the unit, a user may quickly run their hand over the rough edge and sustain a minor cut.It is unknown how the rough edge was caused.As a precaution, steris's supplier of the drying cabinet has been made aware of the event.Steris is working with the user facility to repair the unit.A follow-up mdr will be submitted once the unit is repaired.
Event or Problem Description
The user facility reported an employee received a small cut on her hand while cleaning their 6000 series reliance endoscope drying and storage cabinet.The employee self-administered a bandage and continued working.
Additional Manufacturer Narrative
A steris service technician made the repairs to the 6000 series reliance endoscope drying and storage cabinet, tested the function and operation of the device, and returned it to service.No additional issues have been reported.

• Brand Name: RELIANCE
• Common Device Name: 6000 SERIES RELIANCE ENDOSCOPE DRYING AND STORAGE CABINET
• Manufacturer (Section D): CORPORATION STERIS CANADA; 490 boulevard armand-paris; quebec, G1C 8 A3; CA G1C 8A3
• Manufacturer (Section G): CORPORATION STERIS CANADA; 490 boulevard armand-paris; quebec, G1C 8 A3; CA G1C 8A3
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 20199974
• Report Number: 9680353-2024-00029
• Device Sequence Number: 20716680
• Product Code: PUP
• UDI-Device Identifier: 00724995168117
• UDI-Public: (01)00724995168117
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Followup
• Report Date (Section B): 09/12/2024

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: 6000 SERIES
• Device Catalogue Number: REC6162DS
• 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: 08/13/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/12/2024
• Supplement Report FDA Received Date: 02/06/2025
• 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