MAUDE Adverse Event Report: CORPORATION STERIS CANADA RELIANCE; DRYING CABINET

Model Number	6000 SERIES
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	07/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the unit and confirmed the sharp edges.The technician has ordered parts to make the appropriate repairs.A follow-up mdr will be submitted when the repairs are complete.
Event or Problem Description
The user facility reported that two employees received injuries from "sharp edges" while wiping down a 6000 series endo drying cabinet.The first user suffered a minor laceration on her finger and received a bandage from a medical professional.The second suffered a cut on the back of her hand and received steri-strips from a medical professional.
Additional Manufacturer Narrative
To resolve the issue, the appropriate repairs were completed.The unit was tested, confirmed to be operating according to specification, and returned to service.No additional issues have been reported.

• Brand Name: RELIANCE
• Common Device Name: DRYING 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: 19995929
• Report Number: 9680353-2024-00027
• Device Sequence Number: 20978771
• Product Code: PUP
• UDI-Device Identifier: 00724995168124
• UDI-Public: (01)00724995168124
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2024

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: REC6202DS
• 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: 07/16/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 10/29/2024
• 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