MAUDE Adverse Event Report: CLARUS MEDICAL, LLC 2233-513 DIGITAL CHANNEL SCOPE

Model Number	2233-513
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
2233-513 digital channelscope lacked sufficient adhesive which caused irrigation leak into 5190-500 control module.
Event or Problem Description
During the case 12/3/25 they had an issue with a model 2233-513 digital channelscope (lot 520504) leaking irrigation fluid out of the image connector and into the digital control module.No reported patient injury.

• Brand Name: 2233-513 DIGITAL CHANNEL SCOPE
• Common Device Name: CHANNEL SCOPE
• Manufacturer (Section D): CLARUS MEDICAL, LLC; 13355 10th ave n; suite 110; plymouth MN 55441
• Manufacturer (Section G): CLARUS MEDICAL, LLC; 13355 10th ave n; suite 110; plymouth MN 55441
• Manufacturer Contact: mark brown ; 13355 10th ave n; suite 110; plymouth, MN 55441 ; 7635258403
• MDR Report Key: 23953012
• Report Number: 2183911-2025-00002
• Device Sequence Number: 7875301
• Product Code: GWG
• UDI-Device Identifier: 00810004820012
• UDI-Public: (01)00810004820012(17)280402(10)520504
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K223615
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Risk Manager
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 01/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2233-513
• Device Catalogue Number: 2233-513
• Device Lot Number: 520504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 01/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2025
• 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