MAUDE Adverse Event Report: KARL STORZ IMAGING CCU,MODULAR,H3-LINK,US

Model Number	TC300US
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "when inserting the camera, the image goes in and out.The camera port is loose".No negative impact in state of health reported.
Additional Manufacturer Narrative
The customer's complaint was verified.The reported issue was "image goes in and out".Intermittent image issues observed.A functional test confirmed the intermittent image issue, but the camera port was not loose.The intermittent image issue was caused by edac contamination, which will require an edac replacement.It is advised that the customer reviews their ccu and camera handling/processing protocols to ensure they are following approved karl storz methods.Additionally, the customer should inspect their other ccus and cameras for corresponding contamination.The camera card edge is not loose in the connector.The cause of the issue was determined as contamination in the edac receptacle causing the intermittent image issue.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: CCU,MODULAR,H3-LINK,US
• Common Device Name: CCU,MODULAR,H3-LINK,US
• Manufacturer (Section D): KARL STORZ IMAGING; 1 s. los cameros road; goleta CA 93117
• Manufacturer (Section G): KARL STORZ IMAGING; 1 s. los cameros road; goleta CA 93117
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA
• MDR Report Key: 23369080
• Report Number: 2027009-2025-01848
• Device Sequence Number: 18421600
• Product Code: FET
• UDI-Device Identifier: 04048551356517
• UDI-Public: 04048551356517
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131953
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/23/2025

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: TC300US
• Device Catalogue Number: TC300US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 10/23/2025
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown