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

Model Number	TC300US
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to our us facility as documented in section d9, and will later be forwarded to the manufacturing site for investigation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id (b)(4).
Event or Problem Description
The following was reported: "when the camera is plugged in the screen goes blank/black".No negative impact in state of health reported.
Additional Manufacturer Narrative
Device evaluation: the complaint issue was described as "the screen is black, side by side view is not available." the karl storz goleta service department evaluated and documented the following issue with tc300us serial number pv714401-p.The customer's complaint was verified.A functional test confirmed the failure: plugging in a h3-z test fixture camera resulted in a camera head detection, but the ccu would only display a black screen.Troubleshooting found the capacitor c61 was shorted on the tc300us motherboard.After removal of c61 the ccu produced an image and the short was no longer detected.Based on the age of the tc300us motherboard, it will be replaced to address the customer's issue.Ultimately, the motherboard is approaching 12 years old, and the root cause has been determined as c61 failed due to normal wear and tear.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 90245 ; 4242188247
• MDR Report Key: 23881907
• Report Number: 2027009-2025-02458
• Device Sequence Number: 9650407
• Product Code: FET
• UDI-Device Identifier: 04048551356517
• UDI-Public: 04048551356517
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,Followup
• Report Date (Section B): 02/23/2026

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: TC300US
• Device Catalogue Number: TC300US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2025
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 02/23/2026
• 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