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

Model Number	2233-513
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6) digital channelscope lacked sufficient adhesive which caused irrigation leak into (b)(6) control module.This caused the picture to go black.Investigation and corrective action is ongoing.
Event or Problem Description
During a case on 10/24 using a model (b)(6) digital channelscope lot # 520261, the monitor went black.They unplugged the device and noticed irrigation fluid coming out of the connector.They attempted a new model (b)(6) digital channelscope and it did not display an image.They did not have a backup (b)(6) digital control module on hand, so they switched to a different system to finish the case.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; #110; plymouth MN 55441
• Manufacturer (Section G): CLARUS MEDICAL, LLC; 13355 10th ave n,; #110; plymouth MN 55441
• Manufacturer Contact: mark brown ; 13355 10th ave n,; #110; plymouth, MN 55441 ; 7635258445
• MDR Report Key: 23903608
• Report Number: 2183911-2025-00001
• Device Sequence Number: 15359060
• Product Code: GWG
• UDI-Device Identifier: 00810004820012
• UDI-Public: (01)00810004820012(17)280130(10)520261
• Combination Product (Y/N): Y
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 12/28/2025

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: 2233-513
• Device Catalogue Number: 2233-513
• Device Lot Number: 520261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 12/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown